As Regulatory Affairs Manager, you will lead regulatory strategy on a global scale, across a dynamic product portfolio. With responsibility for a small team, you will benefit from industry leading training, and a thriving business model to support you.
- Provide project-specific regulatory strategy, and prepare submissions to secure timely approvals
- Liaising and negotiating with regulatory authorities, customers and distributors
- Maintain up-to-date knowledge of regulatory legislation, guidelines etc
- Ensure the maintenance of all SOP's Procedures in line with current legislation, regulatory authority guidance and best practice
- Represent Regulatory Affairs in project teams providing strategic advice on technical, pre-clinical, clinical matters and the regulatory pathway for development of products
- Lead project teams as necessary for the resolution of regulatory issues
- Review product labelling for all product claims, ensuring supporting data is on file
- Review product and process change requests ensuring compliance with all relevant regulations
- Ensure the maintenance of all regulatory technical documentation such as Technical Files, Design Dossiers and 510(k)s
- Development and management of Regulatory Affairs Associate
- To carry out any other duties as reasonably required by the Company
- Higher degree in medical, biological or chemical sciences preferred.
- Ability to meet the minimum standards outlined in the EU Medical Device Regulation 2017/745 Article 15 - Person responsible for regulatory compliance: ie, formal RA qualification OR a number of years working within a QARA role
- Must have experience in regulatory submissions to the US, including 510k and combination products (experience with PMAs would be an advantage), submissions to the EU, including Class I, IIa, IIb and Class III, experience with animal derived materials would be preferable.
- Experience of medical device registrations for global markets including Canada, Brazil, Australia, Middle and Far East would be an advantage
For more information, or to discuss your career in the Quality Assurance/Regulatory Affairs arena, please contact Holly Evans on firstname.lastname@example.org
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