Description
Medical Device Expert - Regulatory AffairsMain Responsibilities include;
- Define technical and regulatory strategy for medical device product development projects.
- Implement effective technical and regulatory due diligence for all classes of medical device products.
- Ensure medical device status/classification is appropriate and claim support and stability testing is fit for purpose, and any risks are highlighted.
- Provide regulatory leadership for medical devices. Keep up to date with new legislation and influence medical device processes and procedures to reflect industry best practice.
- Evaluative and make recommendations for prospective new products and technologies, in particular, in those areas where the company has the license to innovate.
- Carry out development, testing and define specifications for new medical device products. Act as main technical contact with suppliers for joint venture developments.
- Own relationship with Notified Body/MHRA on a product basis to register/gain approval for new medical device products and ensure ongoing regulatory compliance..
- Act as technical/regulatory representative for medical device change control.
Essential Requirements;
- 5 + years experience of medical device product development with a strong focus on delivery and overcoming technical problems.
- An in depth knowledge of devices, material science and sterile products and experience in gaining regulatory approval as medical device 'manufacturer'.
- A high level of autonomy, and an exposure to functional decision making and the ability to work to legal requirements within ambiguity of a retail/ business organisation.
- A good understanding of product value chains and commercial decision making, the ability to communicate and manage risk to the business by balancing regulations with business objectives.
- Performance leadership skills with a proven record of personal development
If you think you will be suited to this amazing opportunity then please get in touch with Oliver Davies on