Enovis is hiring a Regulatory Affairs Sustaining Specialist for its medical technology business in Hyderabad, India. This is a full-time opportunity within the Regulatory Affairs function, focused on maintaining medical device certifications, technical documentation, and regulatory compliance under the EU Medical Device Regulation (EU MDR) 2017/745.

The position is suited to candidates with a scientific or biomedical education and 1–2 years of Regulatory Affairs experience in the medical device industry. The role involves working closely with product development, quality, clinical, manufacturing, notified bodies, and competent authorities.

Enovis Regulatory Affairs Job Details

About Enovis

Enovis Corporation is an innovation-driven medical technology company focused on clinically differentiated solutions, patient outcomes, and workflow improvements. Its International Surgical division operates within the global medical technology sector, with products and solutions supporting healthcare and orthopedic applications.

For candidates interested in medical device regulatory affairs jobs in Hyderabad, this position offers exposure to technical documentation, regulatory change management, MDR requirements, and interactions with regulatory stakeholders.

Regulatory Affairs Sustaining Specialist – Responsibilities

The selected candidate will support the ongoing regulatory maintenance of medical devices and associated technical documentation.

Key responsibilities include:

• Preparing, updating, and managing technical documentation for medical device registration and maintenance.
• Ensuring regulatory documentation aligns with Regulation (EU) 2017/745 (MDR).
• Collaborating with product development, quality, clinical, and manufacturing teams.
• Gathering information required for medical device technical files.
• Managing regulatory aspects of product and process changes.
• Conducting or supporting reportability assessments for regulatory changes.
• Supporting notifications to notified bodies and competent authorities.
• Managing communications with notified bodies and regulatory authorities.
• Preparing responses to regulatory deficiencies and requests for clarification.
• Contributing to deficiency-report analysis and response preparation.
• Supporting improvements to internal Regulatory Affairs processes.
• Helping improve technical-documentation structures and regulatory notification processes.

Eligibility Criteria

Candidates applying for the Enovis Regulatory Affairs Sustaining Specialist job should meet the following requirements:

Educational Qualification

A degree in a scientific discipline such as:

• Biology
• Chemistry
• Biomedical Engineering
• Related scientific or technical disciplines

Experience

Candidates should have approximately 1–2 years of experience in Regulatory Affairs within the medical device industry.

Technical and Professional Skills

Applicants should have:

• Knowledge of EU MDR 2017/745.
• Understanding of major international medical device regulations.
• Strong documentation and organizational skills.
• Good time and priority management.
• Excellent English communication skills, approximately B2/C1 level.
• Proficiency in Microsoft Office, particularly Excel.
• An accurate and methodical approach to regulatory work.
• Strong interpersonal and collaboration skills.
• Ability to work effectively with multicultural teams.
• Willingness to learn and collaborate across functions.

Estimated salary: ₹5 LPA – ₹9 LPA

Benefits

According to the supplied job posting, Enovis offers a benefits package that includes:

• Medical insurance
• Life insurance
• Accidental insurance
• Leaves
• Holidays

Why This Role Matters for Medical Device Regulatory Professionals

Medical device Regulatory Affairs professionals are responsible for helping organizations maintain compliance throughout a product’s lifecycle. Unlike roles focused exclusively on initial submissions, a sustaining Regulatory Affairs position can involve ongoing technical-documentation updates, product changes, regulatory assessments, deficiency responses, and communication with regulatory bodies.

For professionals building a career in medical device regulatory affairs, experience with MDR, technical files, change management, and notified-body interactions can be relevant to future regulatory positions across the medical technology sector.

How to Apply

Application Link