8 Activity Monitor jobs in India
Plant Head - Medical Device
Ahmedabad, Gujarat
MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd.
Posted 5 days ago
Job Viewed
Job Description
Job Summary:
The Plant Head will be responsible for overall management, planning, and control of plant operations — ensuring optimum utilization of manpower, materials, and machinery while maintaining the highest standards of productivity, quality, safety, and regulatory compliance (ISO 13485, CE, MDR, GMP).
This role requires a strong leader who can align cross-functional teams (Production, QA, QC, Maintenance, Purchase, Stores, HR, ) toward achieving company goals in efficiency, cost control, and on-time delivery , while driving a culture of continuous improvement.
Key Responsibilities:1. Strategic Planning & Operations Control
- Lead day-to-day plant operations to achieve monthly and annual production targets.
- Develop and implement production plans based on demand forecasts and export schedules.
- Monitor KPIs for OEE, productivity, yield, downtime, rejection, and delivery performance.
- Optimize production planning, batch scheduling, and resource allocation to minimize bottlenecks.
2. Quality, Regulatory & Compliance
- Ensure strict adherence to ISO 13485:2016, CE, MDR, and GMP standards across all processes.
- Collaborate with QA and QC to maintain product quality, conduct internal audits, and resolve non-conformities.
- Maintain full traceability and documentation for batch manufacturing, sterilization, and packaging.
- Support internal and external audits (MOH, clients, notified bodies).
3. Team Leadership & Development
- Lead a multidisciplinary team across Production, QA/QC, Maintenance, Purchase, Store, and HR .
- Define departmental KPIs and conduct regular performance reviews.
- Train and motivate employees to ensure accountability, productivity, and safety compliance.
- Foster a culture of teamwork, discipline, and continuous learning.
4. Cost & Efficiency Management
- Monitor manufacturing costs, wastage, and material utilisation to improve profit margins.
- Implement Lean Manufacturing, Kaizen, and 5S principles for continuous improvement.
- Review cost sheets, BOM accuracy, and process efficiency for cost optimisation.
5. Maintenance & Facility Management
- Oversee preventive and breakdown maintenance of machinery, utilities, AHUs, and ETO sterilisation units.
- Ensure uninterrupted production through effective maintenance planning.
- Coordinate for calibration, validation, and facility upkeep as per GMP norms.
6. Production Documentation & Traceability
- Ensure timely Flow of BMR (Batch Manufacturing Record), BPR (Batch Packaging Record) , and other production documents.
- Maintain full traceability from raw material to dispatch.
- Coordinate with QA for change control, deviation, CAPA, and process validation.
7. Safety, Environment & Compliance
- Ensure implementation of EHS (Environment, Health & Safety) standards.
- Conduct regular safety drills, equipment audits, and compliance checks.
- Maintain hygienic and controlled manufacturing environments as per cleanroom classifications.
8. Cross-Functional Coordination
- Collaborate with Purchase, Sales, Planning, and Finance to ensure smooth operations.
- Review production vs. dispatch schedules and support on-time shipment for export orders.
- Participate in management review meetings and strategic business planning.
Key Skills & Competencies:
- Strong leadership, communication, and analytical abilities.
- In-depth understanding of medical device manufacturing processes (injection molding, assembly, ETO sterilization, packaging).
- Familiar with ISO 13485 documentation, CE marking, and GMP systems.
- Sound knowledge of production planning, maintenance, inventory, and manpower management.
- Proficiency in MS Office / ERP systems.
- Decision-making and problem-solving mindset.
Qualification & Experience:
- Bachelor’s / Master’s degree in Engineering, Industrial Management, or Production.
- Minimum 5-10 years of experience in manufacturing, with at least 2 years in a senior leadership role (preferably in medical devices, pharma, or cleanroom manufacturing ).
- Hands-on experience with ISO 13485 audits, ETO sterilization, and CE compliance preferred.
This advertiser has chosen not to accept applicants from your region.
0
Medical Device Sales Representative
Surat, Gujarat
Alp Consulting Ltd.
Posted 5 days ago
Job Viewed
Job Description
Job Opportunity – Cardiac Division |
Leading Medical Devices Company -
Are you working in the Cardiac Devices or Cardiac Pharma space and looking for your next big opportunity?
Join a leading Medical Devices company focused on Cardiac Stents & Balloons as part of our expanding Cardiac Division
Who Can Apply:
️ Candidates currently working on Dealer/Distributor payroll handling Cardiac Stents, Balloons, etc.
️ Professionals from Pharma companies handling only Cardiac Portfolio as:
Therapy Managers
Key Account Managers
Medical Representatives
What We’re Looking For:
Strong technical knowledge of cardiac therapies
Excellent communication skills
1–2 years of experience in the cardiac segment (mandatory for pharma background)
CTC - Depends upon the interview
This advertiser has chosen not to accept applicants from your region.
1
Medical Device Regulatory Lead
Hyderabad, Andhra Pradesh
ArtiXio
Posted 5 days ago
Job Viewed
Job Description
About the Role
We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other global regulatory agencies. This role requires leadership, ownership, and the ability to guide cross-functional teams through complex regulatory pathways.
Key Responsibilities
- Lead the preparation, submission, and management of medical device applications (US FDA 510k, CE Marking, MDSAP, CDSCO, and other markets).
- Ensure compliance with regulatory standards including ISO 13485, 21 CFR 820 , and other applicable regulations.
- Act as the primary contact for Health Authorities, managing queries and responses effectively.
- Oversee regulatory strategy, project planning, and execution for medical device submissions.
- Provide guidance on Quality Management Systems (QMS) and support audits/inspections.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Clinical, Commercial) to align regulatory requirements with business objectives.
- Take ownership of projects, demonstrating leadership and accountability in delivery.
Qualifications
- 4–6 years of experience in medical device regulatory affairs .
- Proven track record with submissions to FDA (510k), CE Marking, CDSCO, and other agencies .
- Strong knowledge of ISO 13485, 21 CFR 820, QMS practices, and international medical device regulations .
- Experience in responding to Health Authority queries and managing regulatory communications.
- Excellent project management, organizational, and leadership skills.
- Ability to work independently, take ownership, and drive results.
Why Join Us
- Opportunity to lead regulatory projects across global markets.
- Work in a dynamic, entrepreneurial, and collaborative environment.
- Be at the forefront of advancing compliance and patient safety in medical devices.
- Apply now via LinkedIn or connect with us to explore this opportunity
This advertiser has chosen not to accept applicants from your region.
2
Senior Security Engineer - Medical Device Cybersecurity & Compliance
Pune, Maharashtra
Arrow Electronics
Posted 2 days ago
Job Viewed
Job Description
**Position:**
Senior Security Engineer - Medical Device Cybersecurity & Compliance
**Job Description:**
Job Description
**Job Title: Senior Security Engineer - Medical Device Cybersecurity & Compliance**
**Experience Level: 5-10 years**
**Key Responsibilities:**
+ Drive end-to-end cybersecurity integration across the medical device product development life cycle, ensuring security is embedded from concept to release.
+ Develop and maintain cybersecurity for medical products, including security requirements specifications, risk assessments, threat models, and product security architecture documentation.
+ Conduct thorough gap assessments to evaluate compliance with IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97 standards, and implement remediation measures.
+ Perform hands-on vulnerability assessments, penetration testing, and secure code reviews of embedded devices, IoMT (Internet of Medical Things) components, and connected systems.
+ Collaborate closely with development, compliance, and regulatory teams to ensure product security measures meet both internal security policies and external regulatory expectations.
+ Support SBOM management, software supply chain risk evaluations, and third-party component analysis to maintain software transparency and mitigate risks.
+ Provide expert input on secure communication protocols, encryption standards, data protection for both at-rest and in-transit data, and cloud-based connectivity of medical systems.
+ Assist in developing incident response strategies and bring working knowledge of HIPAA, GDPR, and HL7 to address data privacy and healthcare-specific regulatory concerns.
+ Contribute to the continuous enhancement of internal secure development processes, tools, and methodologies, while championing security best practices within product teams.
**Required Skills and Qualifications:**
+ Minimum of 6 years of experience in cybersecurity, including at least 3 years focused on medical devices, embedded systems, or IoT security.
+ Proven track record in authoring security design, defining technical requirements, and documenting security architectures aligned with regulatory needs.
+ Hands-on experience in embedded system security including secure boot, firmware security, threat modeling techniques (e.g., STRIDE, DREAD), and product-level risk assessments.
+ Strong understanding of IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97, along with working knowledge of the medical device product development lifecycle and quality standards like ISO 14971.
+ Demonstrated expertise in vulnerability management and penetration testing of connected products across device and cloud ecosystems.
+ Familiarity with data privacy and interoperability standards such as HIPAA, GDPR, and HL7 is highly desirable.
+ Excellent problem-solving skills, critical thinking, and ability to lead gap analysis and remediation activities in regulated environments.
+ Strong collaboration skills with the ability to influence cross-functional teams including R&D, compliance, and product management.
**Location:**
IN-GJ-Ahmedabad, India-Ognaj (eInfochips)
**Time Type:**
Full time
**Job Category:**
Engineering Services
Arrow Electronics, Inc.'s policy is to provide equal employment opportunities to all qualified employees and applicants without regard to race, color, religion, age, sex, marital status, gender identity or expression, sexual orientation, national origin, disability, citizenship, veran status, genetic information, or any other characteristics protected by applicable state, federal or local laws. Our policy of equal employment opportunity and affirmative action applies to all employment decisions personnel policies and practices, or programs.
Senior Security Engineer - Medical Device Cybersecurity & Compliance
**Job Description:**
Job Description
**Job Title: Senior Security Engineer - Medical Device Cybersecurity & Compliance**
**Experience Level: 5-10 years**
**Key Responsibilities:**
+ Drive end-to-end cybersecurity integration across the medical device product development life cycle, ensuring security is embedded from concept to release.
+ Develop and maintain cybersecurity for medical products, including security requirements specifications, risk assessments, threat models, and product security architecture documentation.
+ Conduct thorough gap assessments to evaluate compliance with IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97 standards, and implement remediation measures.
+ Perform hands-on vulnerability assessments, penetration testing, and secure code reviews of embedded devices, IoMT (Internet of Medical Things) components, and connected systems.
+ Collaborate closely with development, compliance, and regulatory teams to ensure product security measures meet both internal security policies and external regulatory expectations.
+ Support SBOM management, software supply chain risk evaluations, and third-party component analysis to maintain software transparency and mitigate risks.
+ Provide expert input on secure communication protocols, encryption standards, data protection for both at-rest and in-transit data, and cloud-based connectivity of medical systems.
+ Assist in developing incident response strategies and bring working knowledge of HIPAA, GDPR, and HL7 to address data privacy and healthcare-specific regulatory concerns.
+ Contribute to the continuous enhancement of internal secure development processes, tools, and methodologies, while championing security best practices within product teams.
**Required Skills and Qualifications:**
+ Minimum of 6 years of experience in cybersecurity, including at least 3 years focused on medical devices, embedded systems, or IoT security.
+ Proven track record in authoring security design, defining technical requirements, and documenting security architectures aligned with regulatory needs.
+ Hands-on experience in embedded system security including secure boot, firmware security, threat modeling techniques (e.g., STRIDE, DREAD), and product-level risk assessments.
+ Strong understanding of IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97, along with working knowledge of the medical device product development lifecycle and quality standards like ISO 14971.
+ Demonstrated expertise in vulnerability management and penetration testing of connected products across device and cloud ecosystems.
+ Familiarity with data privacy and interoperability standards such as HIPAA, GDPR, and HL7 is highly desirable.
+ Excellent problem-solving skills, critical thinking, and ability to lead gap analysis and remediation activities in regulated environments.
+ Strong collaboration skills with the ability to influence cross-functional teams including R&D, compliance, and product management.
**Location:**
IN-GJ-Ahmedabad, India-Ognaj (eInfochips)
**Time Type:**
Full time
**Job Category:**
Engineering Services
Arrow Electronics, Inc.'s policy is to provide equal employment opportunities to all qualified employees and applicants without regard to race, color, religion, age, sex, marital status, gender identity or expression, sexual orientation, national origin, disability, citizenship, veran status, genetic information, or any other characteristics protected by applicable state, federal or local laws. Our policy of equal employment opportunity and affirmative action applies to all employment decisions personnel policies and practices, or programs.
This advertiser has chosen not to accept applicants from your region.
3
Senior Security Engineer - Medical Device Cybersecurity & Compliance
Ahmedabad, Gujarat
Arrow Electronics
Posted 2 days ago
Job Viewed
Job Description
**Position:**
Senior Security Engineer - Medical Device Cybersecurity & Compliance
**Job Description:**
Job Description
**Job Title: Senior Security Engineer - Medical Device Cybersecurity & Compliance**
**Experience Level: 5-10 years**
**Key Responsibilities:**
+ Drive end-to-end cybersecurity integration across the medical device product development life cycle, ensuring security is embedded from concept to release.
+ Develop and maintain cybersecurity for medical products, including security requirements specifications, risk assessments, threat models, and product security architecture documentation.
+ Conduct thorough gap assessments to evaluate compliance with IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97 standards, and implement remediation measures.
+ Perform hands-on vulnerability assessments, penetration testing, and secure code reviews of embedded devices, IoMT (Internet of Medical Things) components, and connected systems.
+ Collaborate closely with development, compliance, and regulatory teams to ensure product security measures meet both internal security policies and external regulatory expectations.
+ Support SBOM management, software supply chain risk evaluations, and third-party component analysis to maintain software transparency and mitigate risks.
+ Provide expert input on secure communication protocols, encryption standards, data protection for both at-rest and in-transit data, and cloud-based connectivity of medical systems.
+ Assist in developing incident response strategies and bring working knowledge of HIPAA, GDPR, and HL7 to address data privacy and healthcare-specific regulatory concerns.
+ Contribute to the continuous enhancement of internal secure development processes, tools, and methodologies, while championing security best practices within product teams.
**Required Skills and Qualifications:**
+ Minimum of 6 years of experience in cybersecurity, including at least 3 years focused on medical devices, embedded systems, or IoT security.
+ Proven track record in authoring security design, defining technical requirements, and documenting security architectures aligned with regulatory needs.
+ Hands-on experience in embedded system security including secure boot, firmware security, threat modeling techniques (e.g., STRIDE, DREAD), and product-level risk assessments.
+ Strong understanding of IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97, along with working knowledge of the medical device product development lifecycle and quality standards like ISO 14971.
+ Demonstrated expertise in vulnerability management and penetration testing of connected products across device and cloud ecosystems.
+ Familiarity with data privacy and interoperability standards such as HIPAA, GDPR, and HL7 is highly desirable.
+ Excellent problem-solving skills, critical thinking, and ability to lead gap analysis and remediation activities in regulated environments.
+ Strong collaboration skills with the ability to influence cross-functional teams including R&D, compliance, and product management.
**Location:**
IN-GJ-Ahmedabad, India-Ognaj (eInfochips)
**Time Type:**
Full time
**Job Category:**
Engineering Services
Arrow Electronics, Inc.'s policy is to provide equal employment opportunities to all qualified employees and applicants without regard to race, color, religion, age, sex, marital status, gender identity or expression, sexual orientation, national origin, disability, citizenship, veran status, genetic information, or any other characteristics protected by applicable state, federal or local laws. Our policy of equal employment opportunity and affirmative action applies to all employment decisions personnel policies and practices, or programs.
Senior Security Engineer - Medical Device Cybersecurity & Compliance
**Job Description:**
Job Description
**Job Title: Senior Security Engineer - Medical Device Cybersecurity & Compliance**
**Experience Level: 5-10 years**
**Key Responsibilities:**
+ Drive end-to-end cybersecurity integration across the medical device product development life cycle, ensuring security is embedded from concept to release.
+ Develop and maintain cybersecurity for medical products, including security requirements specifications, risk assessments, threat models, and product security architecture documentation.
+ Conduct thorough gap assessments to evaluate compliance with IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97 standards, and implement remediation measures.
+ Perform hands-on vulnerability assessments, penetration testing, and secure code reviews of embedded devices, IoMT (Internet of Medical Things) components, and connected systems.
+ Collaborate closely with development, compliance, and regulatory teams to ensure product security measures meet both internal security policies and external regulatory expectations.
+ Support SBOM management, software supply chain risk evaluations, and third-party component analysis to maintain software transparency and mitigate risks.
+ Provide expert input on secure communication protocols, encryption standards, data protection for both at-rest and in-transit data, and cloud-based connectivity of medical systems.
+ Assist in developing incident response strategies and bring working knowledge of HIPAA, GDPR, and HL7 to address data privacy and healthcare-specific regulatory concerns.
+ Contribute to the continuous enhancement of internal secure development processes, tools, and methodologies, while championing security best practices within product teams.
**Required Skills and Qualifications:**
+ Minimum of 6 years of experience in cybersecurity, including at least 3 years focused on medical devices, embedded systems, or IoT security.
+ Proven track record in authoring security design, defining technical requirements, and documenting security architectures aligned with regulatory needs.
+ Hands-on experience in embedded system security including secure boot, firmware security, threat modeling techniques (e.g., STRIDE, DREAD), and product-level risk assessments.
+ Strong understanding of IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97, along with working knowledge of the medical device product development lifecycle and quality standards like ISO 14971.
+ Demonstrated expertise in vulnerability management and penetration testing of connected products across device and cloud ecosystems.
+ Familiarity with data privacy and interoperability standards such as HIPAA, GDPR, and HL7 is highly desirable.
+ Excellent problem-solving skills, critical thinking, and ability to lead gap analysis and remediation activities in regulated environments.
+ Strong collaboration skills with the ability to influence cross-functional teams including R&D, compliance, and product management.
**Location:**
IN-GJ-Ahmedabad, India-Ognaj (eInfochips)
**Time Type:**
Full time
**Job Category:**
Engineering Services
Arrow Electronics, Inc.'s policy is to provide equal employment opportunities to all qualified employees and applicants without regard to race, color, religion, age, sex, marital status, gender identity or expression, sexual orientation, national origin, disability, citizenship, veran status, genetic information, or any other characteristics protected by applicable state, federal or local laws. Our policy of equal employment opportunity and affirmative action applies to all employment decisions personnel policies and practices, or programs.
This advertiser has chosen not to accept applicants from your region.
4
Senior Manager/Manager - Projects - Medical Device Testing
Bengaluru, Karnataka
TÜV SÜD
Posted 5 days ago
Job Viewed
Job Description
Key Responsibilities:
- Experiences into testing and certification of Active Medical devices for various 60601 basic and product standards
- Knowledge on ISO 13485, ISO 14971, etc
- Responsible to handle the Active Medical Device business segment of EnE for complete Indian region
- Responsible to develop the business of Active medical devices and sustain the business
- Responsible to drive the challenging targets with Techno-commercial knowledge
- Should work closely with Laboratory team to develop test methods for Active Medical devices
- Should work closely with Sales and Marketing teams
- Responsible to build his strong team across India
- Having experience in handling P&L responsibilities
- Should possess high attributions in winning culture
- Having responsibilities in handling a team of 5-10 experts
- Should have a strong knowledge on Medical Device testing market in India
- Having in-depth knowledge of Active Medical equipment’s requirements for various countries
- Should have a strong command on Active medical device regulations for India & Global
- Should have a strong presentation, communication and interpersonal skills
Education & Work Experiences:
- Bachelor of Engineering or B.tech
- 12 - 15 Years of Work Experiences
This advertiser has chosen not to accept applicants from your region.
5
Senior Clinical Operations Manager - Remote Patient Monitoring
500001 Hyderabad, Andhra Pradesh
₹70000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client is seeking an experienced and dedicated Senior Clinical Operations Manager to oversee their innovative remote patient monitoring programs. This role, based out of Hyderabad, Telangana , offers a hybrid work arrangement, allowing for a blend of in-office collaboration and remote flexibility. You will be responsible for managing the day-to-day operations of clinical teams focused on delivering high-quality remote patient care. This includes supervising and mentoring clinical staff (nurses, care coordinators), ensuring adherence to clinical protocols and patient care standards, and optimizing workflows for maximum efficiency and effectiveness. The ideal candidate will possess a strong understanding of healthcare operations, particularly in the realm of telehealth and chronic disease management. You will play a key role in implementing and refining clinical processes, managing patient enrollment and engagement strategies, and ensuring regulatory compliance (e.g., HIPAA). Experience with electronic health records (EHR) systems and remote patient monitoring platforms is essential. Your responsibilities will also include performance monitoring, data analysis to identify trends and areas for improvement, and contributing to the development of new clinical services. You will collaborate closely with IT, product development, and other key stakeholders to enhance the remote monitoring technology and patient experience. Excellent leadership, communication, and organizational skills are paramount for this role. We are looking for a compassionate and results-oriented individual who is passionate about leveraging technology to improve patient outcomes and healthcare accessibility. This is an exciting opportunity to lead and grow a critical component of our client's healthcare services.
Key Responsibilities:
Key Responsibilities:
- Manage and lead teams of clinical staff providing remote patient monitoring services.
- Ensure adherence to clinical protocols, best practices, and regulatory requirements (e.g., HIPAA).
- Oversee daily operations, including patient scheduling, data monitoring, and intervention coordination.
- Develop and implement strategies to optimize patient enrollment, engagement, and retention.
- Monitor key performance indicators (KPIs) and analyze data to identify trends and areas for improvement.
- Collaborate with IT and product teams to enhance remote monitoring technology and platforms.
- Provide training and ongoing support to clinical staff.
- Contribute to the development and refinement of clinical services and workflows.
- Manage relationships with healthcare providers and external partners.
- Bachelor's degree in Nursing, Healthcare Administration, or a related clinical field.
- Master's degree preferred.
- Minimum of 5 years of experience in healthcare operations, with at least 2 years in a management or supervisory role.
- Proven experience in telehealth, remote patient monitoring, or chronic disease management programs.
- Strong understanding of clinical workflows, healthcare regulations, and patient care standards.
- Proficiency with EHR systems and remote patient monitoring software.
- Excellent leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Experience in a hybrid work environment is a plus.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Activity monitor Jobs in India !
6