9,200 Regulatory Standards jobs in India
Quality Assurance Regulatory Affairs
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- Qualtiy Assurance and Regulatory Affairs
- Ensure compliance with regulatory requirements, including API manufacturing, CRAMs, document review, and residential inspections.
- Develop and implement effective quality control processes to maintain high-quality products.
- Preparing and Submitting Drug Master Files to customers and to regulatory bodies
- Conduct regular audits and assessments to identify areas for improvement in pharmaceutical operations.
- Preparation and review of validation protocols, reports, apex documents, and departmental SOPs. as per cGMP guidelines / WHO/EU GMP etc.
- To ensure that product are manufactured in compliance with cGMP requirement.
- To monitor, track arrange for the equipment, utility, process, cleaning, vendor and other qualification/validation related activities.
- Monitoring of validation activities.
- Prepare and review of validation master plan.
- Reviews of executed validation document for equipments, media fill, utility, HVAC, water system.
- Review of executed BMR, Media fill.
- Prepare review of standard operating procedure related validation.
- Responsible for Inspections from regulatory agencies, consultants, service agencies etc. for factory premises.
- Ensure the final checking of the finish product before releasing the batch.
- To ensure that the product are correctly processed and checked according to define procedure.
- Co-ordination is made for the manufacturer, supply and use of the correct starting and packing materials.
- Review of validation master documents.
- To check the effectiveness and applicability of the quality assurance system as per the instruction of HOD QA.
- To prepare and review the SOP for QA department and other SOP originating from QA and to review the SOP of all departments.
- Review of the BMR / BPR Filled by the Production before final release of the product and final checking of the finished product before releasing the batch for dispatch.
- To monitor and review annual product quality review report for the product.
- To review the Qualification / Validation protocols / report for equipment qualification / process validation / cleaning validation.
- To review the calibration certificate / report.
- Approve reviewing training activities; and imparting in house training.
- To carry out all such duties that assigned by HOD QA from time to time upon requirement from management.
- Responsible to conduct on job and departmental trainings to QA Personnel.
Pay: ₹20,000.00 - ₹35,000.00 per month
Schedule:
- Day shift
**Education**:
- Bachelor's (preferred)
**Experience**:
- total work: 4 years (preferred)
Work Location: In person
Quality Assurance & Regulatory Affairs Manager
Posted today
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Qualification:
Bachelors or Masters in Biomedical Engineering and at least 2 years of experience in quality management system for medical device (ISO 13485).
Experience and skills
A candidate should have hands on experience on implementing quality management system ISO 13485.
Candidates must provide details of QMS projects handled.
Knowledge of ISO and IEC standards such as ISO 13485, IEC 60601 standards
Qualified internal auditor for ISO 13485
Knowledge of Indian Medical device rule,2017.
Fundamental understanding of product development process (for new product development) which includes knowledge of hardware, software, mechanical and regulatory development activities amongst others
Roles and responsibilities
Manage quality assurance procedure and records.
Plan and guide various labs test for innovative medical device.
Prepare and submit device dossiers to regulatory bodies as per client needs.
Plan and conduct internal audits. Participate in the corrective and preventive action process.
Imparting QMS training to new joinee.
Identifying regulatory design input for design team.
Identifying device related risk as per applicable regulatory requirements.
Ensuring medical standard compliance - Studying the applicable product standards for medical devices, analysis of all applicable sections,
documenting the requirements and design aspects based on the study. Helping and tracking the implementation.
Ensure design and test methodologies meets internal and external regulatory requirements
Excellent understanding of product risk analysis and FMEA processes w.r.t corresponding medical standards (IEC 60601-1,IEC 60601-1-2, ISO 14971 etc).
Detailed analysis of Software related risks and processes according to IEC 62304
Detailed analysis of usability aspects of medical devices according to HFE 75, IEC 62366, IEC 60601-1-6, data security standards etc.
Plan clinical trials for innovative medical device and corresponding regulatory submission related processes and documentation
Working with cross functional teams to ensure compliance to medical standards and applicable regulatory rules to ensure good quality project
deliverables.
Conducting clinical literature search using databases such as PubMed, ClinicalTrials.gov and other internet sources to obtain relevant research papers for the given medical device.
Staying updated on recent trends, developments and advances in medical device standards.
Requirements
Add on skills
Knowhow of FDA, CE and corresponding compliance requirements
Experience in IVD device, combinational medical device
Understanding the requirements the quality system requirements of
Regulation MDR 2017/745 and IVDR 2017/746
Other skills
Strong analytical skills
Detail oriented approach to problems
Strong reviewing skills
Good communication and presentation skills
Focus on achieving goals and delivering results
Collaborate and create alignment in a team environment
Requirements
ISO 13485, IEC 60601, QMS, FDA, CE
Quality Assurance & Regulatory Affairs Manager
Posted today
Job Viewed
Job Description
Qualification:
Bachelors or Masters in Biomedical Engineering and at least 2 years of experience in quality management system for medical device (ISO 13485).
Experience and skills
A candidate should have hands on experience on implementing quality management system ISO 13485.
Candidates must provide details of QMS projects handled.
Knowledge of ISO and IEC standards such as ISO 13485, IEC 60601 standards
Qualified internal auditor for ISO 13485
Knowledge of Indian Medical device rule,2017.
Fundamental understanding of product development process (for new product development) which includes knowledge of hardware, software, mechanical and regulatory development activities amongst others
Roles and responsibilities
Manage quality assurance procedure and records.
Plan and guide various labs test for innovative medical device.
Prepare and submit device dossiers to regulatory bodies as per client needs.
Plan and conduct internal audits. Participate in the corrective and preventive action process.
Imparting QMS training to new joinee.
Identifying regulatory design input for design team.
Identifying device related risk as per applicable regulatory requirements.
Ensuring medical standard compliance - Studying the applicable product standards for medical devices, analysis of all applicable sections,
documenting the requirements and design aspects based on the study. Helping and tracking the implementation.
Ensure design and test methodologies meets internal and external regulatory requirements
Excellent understanding of product risk analysis and FMEA processes w.r.t corresponding medical standards (IEC 60601-1,IEC 60601-1-2, ISO 14971 etc).
Detailed analysis of Software related risks and processes according to IEC 62304
Detailed analysis of usability aspects of medical devices according to HFE 75, IEC 62366, IEC 60601-1-6, data security standards etc.
Plan clinical trials for innovative medical device and corresponding regulatory submission related processes and documentation
Working with cross functional teams to ensure compliance to medical standards and applicable regulatory rules to ensure good quality project
deliverables.
Conducting clinical literature search using databases such as PubMed, ClinicalTrials.gov and other internet sources to obtain relevant research papers for the given medical device.
Staying updated on recent trends, developments and advances in medical device standards.
Requirements
Add on skills
Knowhow of FDA, CE and corresponding compliance requirements
Experience in IVD device, combinational medical device
Understanding the requirements the quality system requirements of
Regulation MDR 2017/745 and IVDR 2017/746
Other skills
Strong analytical skills
Detail oriented approach to problems
Strong reviewing skills
Good communication and presentation skills
Focus on achieving goals and delivering results
Collaborate and create alignment in a team environment
Gm - Quality Assurance & Regulatory Affairs
Posted today
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Job Description
Educational:
- BSc/ M.Sc Science Graduate / Food Microbiologist/Other Relevant Courses.
Experience:
- 15-20 Years experienced in Food or Herbal or Pharma or Nutraceutical industry.
- **Job Description**_
1) Must have experience in handling audits like International FDA, MHRA, Kosher, Halal, FSSC 22000, HACCP and Other regulatory body audits as per Global Food Safety Requirement.
2) Must be PCQI certified
3) Must have Thorough knowledge and experience to handle FDA audit as per 21 CFR (117 ).
- **Contact Details **_
**Pradeep**
** **
**Salary**: Up to ₹100,000.00 per year
**Speak with the employer**
+91
QAra Executive (Quality Assurance & Regulatory Affairs)
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**About Prayasta**
Founded in 2017 in Bangalore, Prayasta operates on the principle of tailoring implants to individuals rather than requiring individuals to conform to standardized implant sizes. In pursuit of this vision, Prayasta has pioneered the world's first 3D printer capable of producing "implant-grade" silicone, facilitating the creation of a diverse array of soft-tissue implants.
Prayasta has received support through various grants, including those from the Department of Science & Technology (DST), Biotechnology Industry Research Assistance Council (BIRAC), Ministry of MSME (MoMSME), Ministry of Electronics and Information Technology (MEITY), Start-up Karnataka, and the National Research Development Corporation (NRDC). The company has also earned acclaim, being honored with the National Start-up Technology Award 2022 from the Technology Development Board (TDB) and securing patents in both India and the USA for its pioneering technology.
Comprising a dynamic and motivated team of engineers, scientists, and entrepreneurs, Prayasta is dedicated to developing globally outstanding products that make a positive impact on society.
**Summary**
**Key Responsibilities**:
- Support the implementation and maintenance of the Quality Management System (QMS) as per ISO 13485 and relevant regulatory requirements.
- Assist in conducting internal audits, supplier audits, and audit readiness for external inspections (e.g., FDA, Notified Bodies).
- Participate in root cause analysis, non-conformance reporting (NCR), and Corrective and Preventive Actions (CAPA).
- Manage documentation control, SOPs, batch records, and quality logs in compliance with QMS standards.
- Coordinate training sessions and maintain training records related to quality and regulatory processes.
- Assist in compiling and maintaining regulatory submissions (e.g., 510(k), CE technical files, country-specific registrations).
- Ensure ongoing compliance with applicable global regulatory requirements (FDA, EU MDR, etc.).
- Monitor and communicate regulatory changes and support impact assessments on products and processes.
- Help prepare Product Dossiers, Risk Management files, and Clinical Evaluation Reports.
- Support product labelling, UDI requirements, and post-market surveillance activities.
- Maintain organized filing systems—both physical and digital.
- Order and track office supplies, equipment, and inventory.
- Schedule meetings, manage calendars, and support general office coordination.
- Assist in preparing reports, letters, and internal communications.
- Support HR and admin tasks such as onboarding documentation and leave tracking.
- Record and process invoices, payments, and expense claims.
- Assist with bank reconciliations, petty cash handling, and ledger maintenance.
- Support month-end and year-end financial processes.
- Coordinate with vendors and clients for payment follow-ups.
- Maintain accurate and up-to-date financial records and documentation.
**Qualifications**:
- Education: Graduate degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field. Additional training in Quality or Regulatory Affairs is an advantage.
- Experience: Minimum 1-3 years of experience in a Quality Assurance and/or Regulatory Affairs role, preferably in the medical device or healthcare industry.
- Standards & Compliance: Working knowledge of ISO 13485, 21 CFR Part 820, and EU MDR. Familiarity with ISO 14971 for risk management is a plus.
- Documentation: Experience in handling QMS documentation, including SOPs, CAPAs, internal audits, and regulatory submissions such as CE technical files or 510(k)s.
- Software Skills: Proficient in Microsoft Office Suite (Word, Excel, PowerPoint). Experience with electronic QMS tools or document control systems is a strong advantage.
- Regulatory Knowledge: Understanding of global regulatory requirements and ability to support registration and compliance activities for different markets (e.g., US, EU, India).
- Communication: Strong verbal and written communication skills with the ability to prepare clear reports, documentation, and correspondence for regulatory bodies and internal teams.
- Attention to Detail: High level of accuracy in handling technical documents, data entries, and compliance records.
- Professionalism & Initiative: Organized, self-driven, and capable of handling tasks independently while working effectively in a cross-functional team.
**Desired Qualifications**:
- Diploma or degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.
- 1-3 years of experience in a Quality Assurance and/or Regulatory Affairs role, preferably in the medical device or healthcare industry.
- Working knowledge of ISO 13485, 21 CFR Part 820, and EU MDR regulatory requirements.
- Proficiency in Microsoft Office, especially Excel and Word; experience with QMS or document control software is an advantage.
- Excellent att
Quality Assurance Technician, Quality Assurance
Posted today
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Job Description
Are you passionate to improve Quality of highly scalable distributed software systems for International Seller Growth tech team, come join us in this exciting journey.
Key job responsibilities
- Design and execute systems to check for issues
- Document test cases
- Perform and document risk analysis
- Record test progress and results
- Code automated tests
- Create test plans
- Develop standards and procedures to determine product quality and release readiness
- Discover bugs within software
- Drive innovation and streamline overall testing processes
- Identify, isolate, and track bugs throughout testing
- Identify any potential problems that users might encounter
- Perform manual and automated testing
- Research and analyze product features being tested
- Research new tools, technologies, and testing processes
- Review user interfaces for consistency and functionality
About The Team
The International Seller Growth Team's mission is to set our worldwide Sellers up for success across our global Marketplaces. We deliver needle-moving initiatives which provide a seamless experience to Amazon Sellers at each step of the Seller journey. We enable Sellers across the world to list millions of products at scale across multiple categories and dozens of languages in our global Marketplaces. This includes automatically mapping Seller product information to the Amazon namespace and automating complex decision making (like Product Classification in our Catalog) on the Seller's behalf. We provide Sellers with strategic selling recommendations based on hybrid demand signals (like high-value products they should start selling in additional Marketplaces). We partner with Amazon Business to build best-in-class solutions that allow B2B Sellers to reach a wide customer base and drive billions of dollars in revenue. We continuously improve the state of the existing catalog created by Amazon Sellers through smart solutions that automatically identify and fix defects using self-learning heuristics leveraging textual and image-based signals
Basic Qualifications
- Minimum 1+ years of experience
- Bachelors degree
- Manual testing experience (UI, API, DB)
- Automation and coding/scripting knowledge
Preferred Qualifications
- Automation framework knowledge
Skills Required
Scripting, Coding, Automation Framework
Quality Assurance
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• Design, develop, and integrate a highly automated system and solutions testing environment for private and public cloud environments.
• Knowledge of quality assurance terminology, 4G/5G Networking testing, methods, and tools
• Detailed understanding of SDN, NFV, and VMware Virtualization technologies.
• Understanding the CMMI ( Capability Maturity Model Integrated) and TMM (Test Maturity model)
• Demonstrated knowledge of testing best practices, version control practices, and defect management practice
• Proficient in developing pipeline code with one of the CI/CD/CT tool such as GitLab CI, Jenkins
• Experience with 5G Service Based Architecture, Call flows
• Knowledge of security is a plus.
• Knowledge with NFV SDN Standard Architecture
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Quality Assurance
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StarClinch offers the thrill of working with a young team, the ability to make an immediate impact, and the opportunity to work with a game-changing product that is disrupting the live entertainment business forever. In simple words, StarClinch is India's largest artist booking and discovery platform. We own and execute the entire process from artist shortlist, availability check, negotiation, booking, payment, and escrow.
Our extensive list of models, dance troupe, live bands, photographers, instrumentalists, singers, and performers, serves as a tool to find the best of talents, well suited for any gathering. Our aim is to bridge the gap between a host and an artist, through a secure, cost-effective, and transparent medium, for a successful collaboration. Our office is located inDLF Commercial Centre, Greater Kailash .
Perks: