Regulatory Affairs Sustaining Specialist

Overview

Support the maintenance of medical device certifications for international markets as part of the global Regulatory Affairs organization, working from India with European and Global RA colleagues.

What you'll do

• Prepare, update, and manage technical documentation for the registration and maintenance of medical devices in accordance with Regulation (EU) 2017/745 (MDR).
• Manage the regulatory aspects of product/process changes, including reportability assessments and notifications to Notified Bodies and Competent Authorities.
• Partner cross-functionally with R&D, Quality, Clinical, and Manufacturing teams to gather the information needed to compile technical files, rationales and regulatory evaluations.
• Handle communications with Notified Bodies and Competent Authorities, including responses to deficiencies and requests for clarification.
• Contribute to the analysis of deficiency reports and the preparation of robust, evidence-based responses.
• Actively participate in defining and improving internal regulatory processes (technical documentation structure, change notification workflows).

What you'll need

• Bachelor's or Master's degree in a scientific/technical discipline (B.Sc./M.Sc. in Biology or Chemistry, or B.E./B.Tech in Biomedical Engineering or related field).
• 1–3 years of experience in Regulatory Affairs within the medical device industry.
• Working knowledge of EU MDR and major international regulations and standards applicable to medical devices (e.g. ISO 13485, ISO 14971, ISO 15223-1, ISO 20417, etc.).
• Excellent written and spoken English (B2/C1), essential for daily interaction with global teams.
• Proficiency in Microsoft Office, especially Excel.
• Accuracy, methodical approach, and results orientation.
• Strong interpersonal skills and the ability to thrive in a multicultural, cross-functional environment.
• Willingness to learn, take ownership, and collaborate.
• Availability for short international business trips (2–3 days per quarter).

Nice to have

• Experience supporting audits or Notified Body interactions (e.g., TÜV SÜD).

Details

• Location: Hyderabad, India (Full Remote).
• Department: Regulatory Affairs – Surgical International.