Senior Regulatory Affairs Manager
Salary: Excellent package
Our client is a well-established, dynamic and fast growing international medical devices business.
This is a particularly exciting time for this multi award winning, business as it continues to build on its success and growth. There are significant opportunities for our client to further develop its capabilities, products, export markets and continue to lead in the marketplace internationally.
This appointment will enjoy significant levels of autonomy and responsibility. The successful appointee will lead the regulatory teams and working with the executive team, be responsible for the commercial and operational success of the business, making a significant contribution to the performance of the business.
The successful candidate will enjoy a stimulating and rewarding high profile role within a genuinely exciting and respected business.
Senior Regulatory Affairs Manager
Overall Job Purpose
- To ensure surgical haemostat products meet the relevant global regulatory requirements. To obtain and maintain required regulatory authority approvals, authorizations and clearances. Provide Business Unit Regulatory strategy in line with overall company strategy. To correspond / primary point of contact for regulatory authorities.
- 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 EU Notified Body, US FDA and others as required
- Maintain up-to-date knowledge of regulatory legislation, guidelines etc.
- 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 labeling 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 Design Dossiers, 510(k)s. and PMAs
Key General Responsibilities:
- To obtain product registration by liaison with Regulatory Authorities, Customers and / or Distributors to ensure efficient approval Lead or participate in various project meetings as necessary
- To carry out any other duties as reasonably required by the Company
Key Requirements for the Role
- 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: Higher degree in Medical, Biological or Chemical Sciences preferred
- Must have relevant experience in Regulatory submissions to the US including 510K and PMA’s the EU including Class III Experience of medical device registrations and submissions for absorbable / resorbable / implantable products is essential.
- Experience of medical device registrations and submissions for absorbable / resorbable / haemostatic products would be an advantage Experience with combination products and animal derived materials would be an advantage
- 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 understanding and guide to compliance of the Regulations at all levels within the business.
- Pragmatic approach to regulations and 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
Our client is a successful and well-respected business enjoying an exciting period of opportunity and growth. There are significant opportunities for the business to further develop its capabilities, products, export markets and continue to lead in the marketplace internationally.
This job has now been successfully concluded.