Regulatory Affairs Sustaining Specialist

DJO Tunisie; India; Remote; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Medical, Life, and AccidentalInsurance

Leaves and Holidays

Job summary

Enovis Hyderabad is seeking a Regulatory Affairs Sustaining Specialist to support medical device certifications across international markets. Based in India, you’ll collaborate with European and Global RA teams to keep technical documentation audit-ready and compliant.

You will work with R&D, Quality, Clinical, and Manufacturing to manage files, support audits, and implement regulatory processes, while traveling 2–3 days per quarter as needed.

Qualifications

• Bachelor’s or Master’s degree in a scientific/technical discipline (Biology, Chemistry, 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 (ISO 13485, ISO 14971, ISO 15223-1, ISO 20417).
• Excellent written and spoken English (B2/C1) for global collaboration.

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 R&D, Quality, Clinical, and Manufacturing to compile technical files and regulatory evaluations.
• Communicate with Notified Bodies and authorities, address deficiencies and clarifications.
• Contribute to deficiency report analysis and evidence-based responses.
• Help define and improve internal regulatory processes and workflows.

Skills

Regulatory affairs

English proficiency (B2/C1)

MS Excel

Cross-functional collaboration

Audits & Notified Bodies

Education

BSc Biology

MSc Chemistry

B.E./B.Tech Biomedical Eng

Tools

Microsoft Office

Regulatory databases

Job description

Who We Are

ABOUT ENOVIS™ Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com .

What You’ll Do

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. Why work at Enovis? See for yourself . As a key member of the team, you will play an integral part in helping Enovis drive the medical technology industry forward by transforming patient care and improving patient outcomes.

Regulatory Affairs Sustaining Specialist

Location: Hyderabad, India (Full Remote)

Department: Regulatory Affairs - Surgical International

About the role

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.

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).

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

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Benefits

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

EQUAL EMPLOYMENT OPPORTUNITY Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonab