Regulatory Affairs Manager

A medical device company is looking for a Regulatory Affairs Manager to lead and coordinate the company’s regulatory projects across global markets.

The company develops and manufactures medical device solutions for autologous regenerative applications, operating in a professional, regulated, and international environment. This is a key regulatory role, responsible for new product registrations, maintenance of existing regulatory files, regulatory strategy for products under development, and ongoing communication with external regulatory bodies and partners.

Responsibilities

• Lead and coordinate the company’s regulatory projects across international markets.
• Manage new product registration processes under MDR in Europe and FDA requirements in the U.S., including Class III-related activities.
• Maintain existing registration files and regulatory documentation.
• Support distributors with regulatory requirements, documents, and ongoing regulatory requests.
• Develop regulatory strategies for new products under development.
• Work closely with Notified Bodies worldwide.
• Manage ongoing interfaces with the company’s external regulatory consultants.
• Collaborate with internal teams to support product development, regulatory submissions, documentation, and compliance needs.
• Ensure regulatory activities are aligned with business goals, product requirements, and applicable market requirements.
• Support the company’s long-term regulatory planning and global market access activities.

Required Qualifications

• B.Sc. in a scientific field – must.
• Approximately 5 years of experience in medical device companies – must.
• Experience in regulatory affairs for medical devices – must.
• High level of English – must.
• Strong ability to manage multiple regulatory projects simultaneously.
• Strong written and verbal communication skills.
• Ability to work with internal teams, distributors, Notified Bodies, and external consultants.
• Independent, organized, detail-oriented, and able to build regulatory strategies in a dynamic environment.

JOB NO. 191354