Key responsibilities
1. Assist in preparation, compilation, and maintenance of Technical Documentation (Annex II/III; Art.10(4), (9)) ensuring accuracy, completeness, and alignment with device classification and intended purpose.
2. Coordinate with R&D, Manufacturing, Clinical, Supplier Quality and other teams to collect, verify, and organise information required for Technical Files and submissions.
3. Support preparation and maintenance of Clinical Evaluation documentation (CERs, literature searches, clinical evidence) per Annex XIV and MDR guidance.
4. Assist maintenance of Risk Management per Annex I and ISO 14971, ensuring traceability between hazards, risk controls, residual risks, and verification/validation evidence.
5. Compile and maintain verification and validation records (performance, biocompatibility, software, sterilization, shelf‑life/packaging, stability) required under Annex II.
6. Ensure labelling, IFU, packaging, UDI, and translations comply with MDR and approved Technical Documentation.
7. Maintain document control, revision histories, cross‑reference matrices, and version control to support QMS compliance (Art.10(9), Annex II/III).
8. Prepare submission‑ready Technical Documentation and support Notified Body assessments, audits, inspections, including collating evidence and responding to queries.
9. Identify documentation gaps/non‑conformities, coordinate corrective actions with stakeholders, and update Technical Documentation across the product lifecycle (design changes, CAPA, complaints, PMS/PMCF, vigilance).
10. Support QMS establishment, maintenance, continual improvement, audit preparation (CE marking, ISO 13485), and perform other QA/RA tasks as assigned.
Required qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Biotechnology, or related discipline.
- 3–5 years of experience in Regulatory Affairs / Quality Assurance within the medical device or healthcare sector.
- Basic understanding of EU MDR 2017/745, ISO 13485, and core concepts of medical device Technical Documentation, risk management, and clinical evaluation.
Skills and competencies
- Strong documentation, organizational, and analytical skills, with attention to detail in reviewing technical and clinical content.
- Good written and verbal communication skills in English; ability to draft clear, structured regulatory and technical documents.
- Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
- Ability to work collaboratively in cross‑functional teams and manage multiple tasks with defined timelines.
- Demonstrated interest in medical device regulatory affairs and willingness to learn and adapt to evolving regulatory requirements
Pay: ₹450,000.00 - ₹600,000.00 per year
Benefits:
- Health insurance
- Leave encashment
- Provident Fund
Work Location: In person
