Regulatory Affairs

Responsibilities:

• Conduct periodic compliance reviews and gap assessments against applicable international standards.

• Draft and update regulatory procedures and work instructions.

• Maintain technical documentation in accordance with current regulatory frameworks.

• Administer EUDAMED records and ensure EU MDR alignment.

• Evaluate the regulatory impact of product and process changes.

• Compile and manage documentation for international product registrations, including labeling and coordination with economic operators.

• Track regulatory submissions and maintain associated documentation.

• Support post-market surveillance (PMS) and clinical follow-up (PMCF) processes.

• Review clinical evaluation documentation (CER).

• Manage incident reporting and product recall processes.

• Participate in external audits and regulatory inspections.

Qualifications:

• Academic degree in biomedical engineering, biotechnology, or relevant discipline.

• Minimum 3 years of experience in regulatory roles within the medical device sector.

• Familiarity with CE mark processes and international regulatory standards.

• Strong written and spoken English.

• Competence with Microsoft Office suite.