A leading Medical Device company is seeking a Senior Regulatory Affairs Specialist to manage post-approval regulatory activities for Class III implantable medical devices across international markets.
Responsibilities:
Lead and manage product registrations in EU countries and additional international markets.
Maintain existing registrations and regulatory approvals.
Perform regulatory impact assessments for product, process, labeling, and supplier changes.
Work with regulatory authorities and relevant databases.
Collaborate closely with QA, Clinical, and Operations teams to ensure ongoing compliance.
Requirements: Bachelors degree - an advantage.
Minimum 4-5 years of Regulatory Affairs experience in the Medical Device industry.
Mandatory experience with Class III implantable medical devices.
Hands-on experience with EU MDR, post-approval activities, product registrations, and change control.
Experience working with regulatory authorities.
Strong organizational skills and excellent attention to detail.
Fluent English.
This position is open to all candidates.