We are a market leading Medical Device company and due to continued growth, we have an exciting opportunity available for a Regulatory Affairs Specialist to join our team in King’s Lynn.
There is a large degree of flexibility with this role, though you will be required to be on site at least once a week.
As our new Regulatory Affairs Specialist, you will be responsible for providing specialist regulatory advice and information throughout the Company to understand, plan and support the design, development, and commercialisation of products with a focus on New Product Introduction (NPI) programmes.
- Identify, define, and deliver of Regulatory deliverables for NPI programmes and marketed products as required to ensure product quality and compliance, within agreed cost and timelines
- Develop and maintain up to date relevant legislative, compliance and regulatory knowledge applicable to the company. Ensure that Pharmaceutical, Medical Device and Drug-Device Combination Product Regulatory Affairs policies, procedures and processes are revised as required, to ensure compliance and followed at all times
- You will rigorously manage non-conformances or contrary behaviours where known and ensure that no actions taken by yourself or others sacrifice safety or quality which could put yourself, others or the product integrity at risk
- Keep up to date with the applicable regulatory changes, proactively conduct impact assessments and effectively communicate outcomes
- Provide direction, advice, training and guidance to employees regarding compliance and regulatory issues, including the review and implementation of QMS transactions (e.g. change controls).
- Proven experience in Regulatory Affairs in the Medical Device industry
- Previous experience of interpreting legislative requirements at various stages of a product lifecycle with the ability to translate this information to non-regulatory colleagues.
- Proven leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
- Experience of interpreting and implementing standards and regulations essential.
- Broad background in quality and regulatory compliance of systems and products essential.
- Experience of medical standards and European/ FDA regulations such as ISO 13485, 21 CRF Part 820, ISO 14971, ISO 10993, GMP, European Medical Device Regulation, QSIT.
If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or call 01189 239 234 and ask for Kris Holmes.
Permanent, Full Time
Additional Salary Info
- Industry Sector Engineering, Utilities