(Suite 117) Peel House,
30 The Downs,
Tel: 0161 667 1613
VAT Number: 241 4554 26
Are you an experienced Regulatory Affairs Manager looking to work in an innovative Company? Then look no further as we have an exciting opportunity.
Reporting to the Regulatory Affairs Director, you will ensure all Medtrade products meet the relevant global requirements, obtaining and maintaining required regulatory approvals, authorisations and clearances.
You will provide Business Unit regulatory strategy in line with overall company strategy and correspond with regulatory authorities.
Key Role Responsibilities
• Provide project-specific regulatory strategy to ensure a timely route to market.
• Prepare regulatory submissions where required and secure timely approvals.
• Liaising and negotiating with regulatory authorities.
· Liaising with Customers and/or Distributors.
• Maintain up-to-date knowledge of regulatory legislation, guidelines etc.
• Ensure the maintenance of all Medtrade Standard Operating 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 as detailed below preferred:
The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Without prejudice to national provisions regarding professional qualifications.
· 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
· An excellent verbal and written communicator to ensure compliance of the regulations at all levels within the business.
· Pragmatic approach to regulations to achieve compliance in the most efficient and timely manner.
· Be a fully integrated and positive partner for the business units to drive regulatory submissions through to their ultimate approval.
· Able to demonstrate a solution-focused approach.
· Able to persuade and influence others.
· Able to contribute and work effectively in matrix project teams.
· Able to organise and project manage in a timely and effective way.
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