Regulatory Affairs Specialist
Oliver Care is recruiting for a Regulatory Affairs Specialist to join a company in the medical device industry at their site based in Inverness on a contract basis.
The main purpose of the role will be to:
- Support the Regulatory Affairs Project Leads for new blood glucose monitoring system development projects.
- Support the RA project lead during characterisation, verification and validation, labelling and claims development and support the preparation of pre-market applications to Regulatory Authorities.
- Provide guidance to product development teams and other business partners in terms of conformance with medical device regulations/standards, data required for product submissions, date required to substantiate product claims and the content of labelling, advertising and promotional materials as required.
Further responsibilities will include:
- Researching and keeping up to date with current global regulatory requirements in order to develop global regulatory strategies.
- Partnering with global regulatory affiliates and providing documentation to support international applications for new products and the maintenance of existing product licenses.
- Being involved with the development of best practices for Regulatory Affairs processes and providing guidance and support to colleagues.
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 or technical field with previous experience in a Regulatory/compliance related role within a highly regulated environment.
- Familiar with US and EU medical device regulations and demonstrated success in preparing pre-market applications with working knowledge of eDMS and MS Office programs.
- Excellent communications and interpersonal/negotiation skills with strong project management skills and the ability to work both independently and collaboratively.
This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.
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.
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 CL33518 in all correspondence.