Enovis India is Hiring for Regulatory Affairs Sustaining Specialist Job

Regulatory Affairs Sustaining Specialist – Enovis, Hyderabad

Enovis Corporation is inviting online applications for the role of Regulatory Affairs Sustaining Specialist based at Enovis India – Hyderabad. This is a full-time, full remote opportunity within the Regulatory Affairs – Surgical International department. The role is suited for candidates with medical device regulatory affairs experience who can support international market compliance, technical documentation maintenance, and interactions with global regulatory teams.

Enovis is a medical technology company focused on clinically differentiated solutions that improve patient outcomes and transform workflows. In this position, the selected candidate will work with cross-functional and multicultural teams, including European and Global Regulatory Affairs colleagues, to keep medical device technical documentation audit-ready and compliant.

Job Overview

Key Responsibilities

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

Required Qualifications

• Bachelor’s or Master’s degree in a scientific or technical discipline.
• Accepted educational backgrounds include B.Sc./M.Sc. in Biology or Chemistry, or B.E./B.Tech in Biomedical Engineering or a related field.

Experience Required

• 1–3 years of experience in Regulatory Affairs within the medical device industry.
• Experience supporting audits or Notified Body interactions, such as TÜV SÜD, is required as stated in the job details.

Required Knowledge and Skills

• Working knowledge of EU MDR and major international regulations and standards applicable to medical devices.
• Knowledge of standards such as ISO 13485, ISO 14971, ISO 15223-1, and ISO 20417.
• Excellent written and spoken English at B2/C1 level, required for daily interaction with global teams.
• Proficiency in Microsoft Office, especially Excel.
• Accuracy, methodical approach, and results orientation.
• Strong interpersonal skills and ability to work in a multicultural, cross-functional environment.
• Willingness to learn, take ownership, and collaborate.
• Availability for short international business trips of 2–3 days per quarter is required.

Benefits

• Medical, Life, and Accidental Insurance.
• Leaves and Holidays.

Why This Role Is a Good Opportunity

This role offers exposure to international medical device regulatory requirements, especially EU MDR, and provides the opportunity to work closely with global Regulatory Affairs teams. Candidates with a strong foundation in technical documentation, regulatory evaluations, and Notified Body communication can contribute to maintaining compliant medical device certifications for international markets.

How to Apply

Interested and eligible candidates can apply online through the official Enovis Workday application link given below.

Apply Online for Regulatory Affairs Sustaining Specialist at Enovis