Job Title: Regulatory Affairs Specialist

Company: Frisch Medical Devices Pvt. Ltd.

Location: Ahmedabad

Employment Type: Full-time

Role Overview

We are looking for an experienced Regulatory Affairs professional with robust practical knowledge of EU MDR requirements, particularly for Class III medical devices. The candidate will be responsible for preparing, maintaining, and updating clinical and post-market regulatory documentation and supporting responses to Notified Body queries.

Key Responsibilities

- Prepare, review, and maintain regulatory documents in accordance with EU MDR 2017/745.
- Prepare and update:
- Summary of Safety and Clinical Performance (SSCP)
- Periodic Safety Update Report (PSUR)
- Post-Market Surveillance Plan and Report (PMS)
- Post-Market Clinical Follow-up Plan and Evaluation Report (PMCF)
- Clinical Evaluation Plan and Report (CEP/CER)
- Ensure consistency across clinical, risk-management, post-market, labelling, and technical documentation.
- Review PMS, vigilance, complaint, literature, and PMCF data for inclusion in regulatory reports.
- Coordinate with Quality, Clinical, R&D;, and other departments to obtain supporting evidence.
- Assist in preparing responses to Notified Body observations, nonconformities, and technical-documentation queries.
- Track regulatory submissions,



document revisions, commitments, and closure of outstanding queries.
- Monitor applicable EU MDR guidance documents, MDCG guidance, harmonised standards, and regulatory updates.

Required Qualifications and Experience

- Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, Biotechnology, or a related discipline.
- Minimum three years of relevant experience in medical-device regulatory affairs.
- Strong practical knowledge of EU MDR requirements for Class III medical devices.
- Hands-on experience in preparing and managing SSCP, PSUR, PMS, PMCF, CER, and related technical documentation.
- Strong technical writing, document-review, and cross-referencing skills.
- Ability to independently manage documentation and work with cross-functional teams.

Preferred Experience

- Experience in handling and responding to Notified Body queries.
- Experience with implantable, cardiovascular, or drug-device combination products.
- Experience working with a medical-device manufacturer or regulatory consultancy.

Interested candidates may send their updated CV to [email protected] , mentioning “Regulatory Affairs” in the subject line.

📌 Regulatory Affairs Specialist (Ahmedabad)
🏢 Frisch Medical Devices Private
📍 Ahmedabad