Regulatory Market Access Specialist

About the role

The Regulatory Market Access Specialist will join Enovis' market access team to bring new and modified medical devices to international markets while ensuring ongoing regulatory compliance. This role provides hands‑on regulatory affairs support for product approvals, renewals, and re‑registrations, working closely with cross‑functional teams.

Key responsibilities

• Prepare and process documentation for new product introductions and modifications in international markets.
• Act as a core team member on new product development and sustaining projects, providing regulatory feedback throughout the product lifecycle.
• Collaborate with the market access team and other functions to resolve regulatory and technical issues raised by agencies.
• Prepare international regulatory registrations, define required approvals, and manage product release under regulatory controls.
• Review and approve design and manufacturing changes, ensuring compliance and notifying license holders.
• Maintain regulatory documentation for audits and submission packages, and provide regulatory training to cross‑functional teams.

Required profile

• Bachelor's or Master's degree in a scientific/technical discipline (e.g., Biology, Chemistry, Biomedical Engineering).
• Minimum 2 years of experience as a Regulatory Affairs Specialist in the medical device industry.
• Strong understanding of EU MDR and major international regulations and standards.
• Ability to manage multiple projects, prioritize tasks, and communicate effectively in English.

Required skills

• Knowledge of EU MDR, ISO 13485, ISO 14971, ISO 15223-1, ISO 20417.
• Experience with regulatory submissions for medical devices in international markets.
• Proficiency in Microsoft Office, especially Excel.
• Familiarity with Agile PLM, Power BI or similar tools (advantageous).