Medical Device Regulatory Operations Associate (2–3+ Years Experience)

Chennai, India Full-Time 2–3+ Years Medical Devices | Regulatory Affairs | Medical Writing

About the Role

We are expanding our Medical Device Regulatory Operations team and are looking for professionals who enjoy working with technical documentation, clinical evidence, regulatory compliance, and structured problem solving.

This role is ideal for candidates who have hands-on experience supporting Medical Device Regulatory documentation and want to build expertise in global regulatory operations rather than purely regulatory strategy.

You will work with international medical device manufacturers, consulting companies, and regulatory teams supporting products across the entire product lifecycle—from product development through post-market surveillance.

Key Responsibilities

Regulatory Documentation Support

Support preparation and maintenance of Technical Documentation (EU MDR Annex II & III).
Perform Technical Documentation Quality Control (QC) Reviews.
Support Design History File (DHF) documentation and remediation activities.
Review documentation for consistency across regulatory files.
Assist in Regulatory Documentation Maintenance activities.

Clinical & Medical Writing Support

Conduct scientific literature searches using PubMed, Cochrane Library, Google Scholar, and other databases.
Perform literature screening and evidence extraction.
Prepare evidence tables and literature summaries.
Support Clinical Evaluation Report (CER) operations.
Support Clinical Evaluation Plan (CEP) and PMCF documentation.
Assist in State-of-the-Art literature reviews.

Post-Market Surveillance (PMS)

Perform literature surveillance activities.
Support Post-Market Surveillance documentation.
Review complaint trends and publicly available safety information.
Support Periodic Safety Update Report (PSUR) documentation.
Assist with PMS Report preparation.

Risk Management & Traceability

Support Risk Management documentation aligned with ISO 14971.
Perform GSPR Traceability Reviews.
Verify consistency between Risk Management File, CER, IFU, Technical Documentation, and Verification & Validation records.

Labeling & IFU Review

Review Instructions for Use (IFU).
Support labeling consistency reviews.
Verify alignment with regulatory documentation.
Identify documentation inconsistencies and prepare review observations.

Regulatory Intelligence

Monitor updates from EU MDR, MDCG Guidance, FDA Medical Devices, and UK MHRA.
Prepare concise regulatory intelligence summaries for internal teams and clients.

Documentation Quality

Perform document formatting and QC reviews.
Ensure version consistency across document sets.
Maintain document traceability.
Support document lifecycle management.

Desired Educational Qualification

Bachelor's or Master's degree in:

Biomedical Engineering Biotechnology Pharmacy Life Sciences Medical Devices Clinical Research Biomedical Sciences Bioinformatics Related Disciplines

Experience Required

2–3 years in Medical Device Regulatory Affairs or Regulatory Operations.
Experience supporting Technical Documentation.
Experience in literature review or medical writing.
Experience working with global medical device regulations is preferred.

Technical Skills

Candidates should have exposure to:

EU MDR 2017/745 FDA Medical Device Regulations ISO 13485 ISO 14971 Clinical Evaluation (CER) PMS PMCF GSPR Technical Documentation Design History File (DHF) Risk Management Documentation Labeling & IFU Review

Good to Have

PubMed, Cochrane Library, and Google Scholar.
EndNote / Reference Management Tools.
Microsoft Word (Advanced Formatting) and Excel.
Document Management Systems.
eQMS / PLM platforms (preferred but not mandatory).

Core Competencies

Have excellent analytical thinking skills.
Enjoy reading scientific and regulatory literature.
Can identify inconsistencies across technical documents.
Possess strong medical writing skills.
Have exceptional attention to detail.
Are process-oriented and quality-focused.
Can manage multiple projects simultaneously.
Communicate effectively with global teams.
Take ownership and demonstrate a continuous learning mindset.

What You’ll Work On

Clinical Evaluation Reports (CER) Post-Market Surveillance (PMS) PMCF Documentation Technical Documentation Reviews DHF Remediation Support GSPR Traceability Reviews Literature Surveillance Clinical Evidence Extraction Regulatory Intelligence Labeling & IFU Reviews Regulatory Documentation Maintenance

What You’ll Gain

Exposure to global MedTech manufacturers and regulatory consulting firms project.
Hands-on experience across the complete Medical Device Regulatory lifecycle.
Advanced training in MDR, FDA, ISO 13485, ISO 14971, and clinical evidence generation.
Opportunities to work on Class I, II, and III medical devices.
Career growth in Medical Device Regulatory Operations and Medical Writing.
Participation in international regulatory projects and cross-functional teams.

Ideal Candidate Profile

This role is ideal for someone who enjoys solving documentation challenges, reviewing scientific evidence, and supporting regulatory teams behind the scenes. If you are passionate about quality, structured thinking, and medical device compliance, you’ll find excellent opportunities to grow with us.

How to Apply

Please submit your resume and cover letter outlining your experience and why you are a great fit for this role.

Apply Now