The Senior Regulatory Specialist will join the Regulatory Affairs, clinical & Compliance Team based in the UK,
As a Senior Regulatory Specialist you will be responsible for managing In-Vitro Diagnostic (IVD) Medical Device regulatory submissions and regulatory compliance activities in line with corporate and divisional objectives.
In addition, the position will provide regulatory support to customers with respect to legislative requirements for the market place, mainly EMEA.
• Compile, review and maintain regulatory submissions, Technical Files, and labelling for completeness and quality.
• Identifies regulatory requirements for new product and changes to existing products.
• Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations.
• Review and approve product labelling/marketing materials for compliance with applicable regulations and standards.
• Review new and existing regulations, guidance documents and standards, and prepare comments based on impact to product and business.
• Support post-market surveillance and vigilance activities.
• Participate in internal and external company regulatory/quality audits, and assist corporate in carrying out GMP cross-site audits.
• Participate in customer audits/technical meetings when applicable.
• Develop regulatory affairs internal policies and procedures, and provide internal trainings as and when required.
• Bachelor’s degree in Biology or similar field, from an accredited college or university or equivalent experience.
• A strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions and Technical Files.
• Experience of communicating with Regulatory Authorities and Distributors
• Experience in clinical trials, specifically regulatory activities and submissions for the trials
• Experience in regulatory audits, ISO certification, GMP requirements and document control.