Regulatory Affairs Sustaining Specialist

Job Title

Regulatory Affairs Sustaining Specialist

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.

Main Responsibilities

• Preparation, updating, and management of technical documentation for the registration and maintenance of medical devices in accordance with Regulation (EU) 2017/745 (MDR).
• Cross-functional collaboration with product development, quality, clinical and manufacturing teams to gather necessary information for compiling technical files.
• Regulatory management of product/process changes (e.g., reportability assessment, notification of changes to notified bodies/competent authorities).
• Handling communications with notified bodies and competent authorities (e.g., responses to deficiencies and/or requests for clarification).
• Contribution to the analysis of deficiency reports and preparation of responses.
• Active participation in defining and improving internal regulatory management processes (e.g., structure of technical documentation, notification processes).

Requirements

• Degree in scientific disciplines (Biology, Chemistry, Biomedical Engineering, or related fields).
• At least 1-2 years of experience in Regulatory Affairs within the medical device industry.
• Knowledge of MDR and major international regulations applicable to medical devices.
• Good time and priority management skills.
• Excellent command of English (B2/C1 level).
• Proficiency in Microsoft Office, especially Excel.
• Accuracy, methodical approach, and results orientation.
• Strong interpersonal skills and ability to work in multicultural teams.
• Willingness to learn and collaborate.
• 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.