Regulatory Affairs Sustaining Specialist

About the role

Enovis is seeking a Regulatory Affairs Sustaining Specialist to join its International Surgical division in Hyderabad. The role focuses on preparing and managing technical documentation to keep medical device certifications compliant with EU MDR regulations and overseeing product change management.

Key responsibilities

• Prepare, update, and manage technical documentation for registration and maintenance of medical devices in accordance with Regulation (EU) 2017/745 (MDR).
• Collaborate cross‑functionally with product development, quality, clinical, and manufacturing teams to gather information for technical files.
• Manage regulatory aspects of product and process changes, including reportability assessments and notifications to notified bodies.
• Handle communications with notified bodies and competent authorities, responding to deficiencies or clarification requests.
• Contribute to analysis of deficiency reports and preparation of responses.
• Participate in defining and improving internal regulatory management processes.

Required profile

• Degree in a scientific discipline (Biology, Chemistry, Biomedical Engineering, or related).
• 1–2 years of experience in Regulatory Affairs within the medical device industry.
• Knowledge of MDR and major international medical device regulations.
• Strong time and priority management skills.
• Excellent command of English (B2/C1 level).
• Accuracy, methodical approach, and results orientation.
• Strong interpersonal skills and ability to work in multicultural teams.
• Willingness to learn, collaborate, and travel internationally for short trips (2–3 days per quarter).

Required skills

• Proficiency in Microsoft Office.
• Advanced use of Microsoft Excel.

What we offer

• Comprehensive benefits package including medical, life, and accidental insurance.
• Leaves and holidays.