Regulatory Affairs Sustaining Specialist

DJO Global; Hyderabad; Remote; INR 800,000 - 1,600,000; Full time

Job summary

DJO Global in Hyderabad, India, seeks an experienced Regulatory Affairs Sustaining Specialist to maintain medical device certifications for international markets. You will work with a cross-functional, multicultural team to keep technical documentation audit-ready and compliant under MDR.

You will manage regulatory aspects of product changes, liaise with Notified Bodies and authorities, and help improve internal processes.

Qualifications

• Bachelor's or Master's in a scientific/technical discipline.
• 1–3 years of Regulatory Affairs experience in medical devices.
• Knowledge of EU MDR and ISO 13485/14971/15223-1/20417.
• Excellent English communication (spoken and written).
• Proficient in MS Office, especially Excel.
• Experience supporting audits or Notified Body interactions (e.g., TVSD).
• Willingness for short international travel (2–3 days per quarter).

Responsibilities

• Prepare, update, and manage technical documentation for registration and maintenance of medical devices per MDR.
• Manage regulatory aspects of product/process changes, including reportability assessments and notifications to Notified Bodies and authorities.
• Collaborate with RD, Quality, Clinical, and Manufacturing to gather information for regulatory files and evaluations.
• Communicate with Notified Bodies and authorities, addressing deficiencies and clarifications.
• Support analysis of deficiency reports and prepare robust responses.
• Contribute to defining and improving internal regulatory processes and workflows.

Skills

Regulatory Affairs

English proficiency

Cross-functional collaboration

Education

BSc/MSc in biology/chemistry or BE/BTech in biomedical engineering

Tools

Microsoft Excel

Job description

Job Summary

We are looking for an experienced Regulatory Affairs Sustaining Specialist to join our global Regulatory Affairs organization, supporting the maintenance of medical device certifications for our international markets. Based in India, you will work as part of a cross-functional, multicultural team and collaborate closely with our European and Global RA colleagues to keep our technical documentation audit-ready and compliant.

Location: Hyderabad, India (Full Remote)

Responsibilities

• 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 RD, 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).

Requirements

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

Availability for short international business trips (2-3 days per quarter) is required.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.