Medical Device Expert
Oliver Care is recruiting for a Medical Device Expert to join a company in the Medical Device industry at their site based in the East Midlands on a permanent basis.
The main purpose of the role will be to:
- Provide Regulatory leadership for medical devices, keeping up to date with new legislation and reflect industry best practice. Define technical and regulatory strategy for medical device product development projects and implement effective technical and regulatory due diligence for all classes of medical devices.
- Ensure robust supporting data, that the status and classification of devices is appropriate, that support and stability testing is fit for purpose and highlight any key risks.
- Evaluate and make recommendations for possible new products and technologies and carry out the development, testing and define specifications for new products.
Further responsibilities will include:
- Ensuring that IP aspects of medical devices are actively managed, the appropriate strategy is implemented and that all risks are highlighted as well as providing technical support when required.
- Inputting into technical wording for product packaging and approving regulatory aspects of wording and artwork.
- Building a relationship with the Notified Body/MHRA on a product basis to gain approval for new products and ensure ongoing regulatory compliance. Acting as a technical/regulatory representative for medical device change control and coach junior members of the team.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in a scientific field with significant experience in medical device product development and gaining regulatory approval as a device manufacturer.
- A strong focus on delivery and overcoming technical problems with in-depth knowledge of devices, material science and sterile products.
- Strong communication skills with commercial decision making and performance leadership skills as well as the ability to manage risk to business.
This is an excellent opportunity to join a company renowned for developing exceptional medical devices with an expanding range of products and a fantastic reputation for new product development.
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30647 in all correspondence.