Regulatory Affairs Specialist

Regulatory Specialist Full-time, permanent position - Reporting to the Regulatory Manager

We have a requirement for a Regulatory Specialist who will assist in ensuring all regulatory requirements are up to date in all departments.

Main Duties:

• Assist in the preparation, compilation and submission of premarket regulatory documentation, including EU IVDR submission, 510(k) submissions and other international filings, ensuring accuracy, completeness and adherence to regulatory requirements.
• Review, maintenance and approval of technical documentation of products, in compliance with the relevant regulations and standards.
• Review complaints, CAPAs and non-conformances for regulatory reporting for CE-IVD marked products.
• Assist in preparation, maintenance and approval of Risk Management and Post Market Surveillance Files
• Review and approval of artwork (labels, instructions for use) for compliance with applicable regulatory requirements and international standards.
• Review change controls for impact on regulatory compliance.
• Monitor changes in legislation, standards and guidance documents related to products and communicate findings to cross functional teams as required.
• Assist in distribution process to ensure regulatory compliance.
• Support regulatory audits and inspections.
• Maintain appropriate regulatory records.
• Review and approve internal and external queries and requests.
• Collaborate effectively with cross functional teams such as Quality and R&D to gather necessary information and align regulatory activities with product development milestones.

Essential Criteria:

• BSc in Molecular Biology or a relevant discipline.
• Minimum 3 years' experience working in a regulatory role for a Medical Device or In Vitro Diagnostic Company.
• Experience in reviewing and approving technical documentation as per EU/US regulations.
• Good working knowledge of ISO 13485, ISO 14791 and IVDR/MDR.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work to tight deadlines
• Good initiative and team player
• Strong writing, verbal and interpersonal skills.

Desirable Criteria:

• Experience supporting product launches in new markets.
• Experience in audits or inspections.
• Experience in health authority interactions.