Regulatory Specialist
Full-Time | Permanent
Our client is seeking a Regulatory Specialist to support regulatory compliance activities across the organisation and ensure adherence to applicable regulatory requirements and quality standards.
Key Responsibilities
Assist in the preparation, compilation, and submission of pre-market regulatory documentation, including EU IVDR submissions, 510(k) submissions, and other international regulatory filings, ensuring accuracy, completeness, and compliance with relevant requirements.
Review, maintain, and approve technical documentation for products in accordance with applicable regulations and standards.
Review complaints, CAPAs, and non-conformances to assess regulatory reporting requirements for CE-marked IVD products.
Assist in the preparation, maintenance, and approval of Risk Management and Post-Market Surveillance documentation.
Review and approve product artwork, including labels and Instructions for Use (IFUs), to ensure compliance with regulatory requirements and international standards.
Review change controls and assess their impact on regulatory compliance.
Monitor changes in legislation, standards, and guidance documents relevant to the product portfolio and communicate updates to cross-functional teams as required.
Support distribution activities to ensure ongoing regulatory compliance.
Participate in regulatory audits and inspections.
Maintain accurate and up-to-date regulatory records.
Review and approve internal and external regulatory queries and requests.
Collaborate with cross-functional teams, including Quality and R&D, to gather necessary information and align regulatory activities with product development timelines.
Essential Requirements
Bachelor's degree in Molecular Biology or a related scientific discipline.
Minimum of 3 years' experience in a regulatory affairs role within the Medical Device or In Vitro Diagnostic (IVD) industry.
Experience reviewing and approving technical documentation in accordance with EU and US regulatory requirements.
Strong working knowledge of ISO 13485, ISO 14971, and IVDR/MDR regulations.
Ability to manage multiple priorities in a fast-paced environment.
Proven ability to work effectively to tight deadlines.
Self-motivated with strong initiative and a collaborative approach to teamwork.
Excellent written, verbal, and interpersonal communication skills.
Desirable Requirements
Experience supporting product registrations and launches in new international markets.
Experience participating in regulatory audits and inspections.
Experience interacting with regulatory authorities and health agencies.
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