Regulatory Affairs Specialist
Oliver Care at CK Clinical 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 RA project leads for new blood glucose monitoring system development projects.
- Support the RA project lead during characterisation, verification & validation, labelling and claims development as well as supporting the preparation of pre-market applications to regulatory agencies.
- Provide guidance to product development teams and other business partners as required regarding conformance to medical device regulations and standards, data required for product submissions and to substantiate product claims and the content of labelling, advertising and promotional materials.
Further responsibilities will include:
- Researching and consolidating global regulatory requirements to enable the development of global regulatory strategies.
- Partnering with global regulatory affiliates and providing documentation to support international applications for new products and licence maintenance.
- Assisting in the development of best practices for RA processes and provide support and guidance to other regulatory staff.
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 or compliance role in a highly regulated environment.
- Familiarity with EU/US medical device regulations and demonstrated success in preparing medical device pre-marketing applications.
- Excellent verbal and written communication skills with strong project management skills and familiarity with MS Office programs and electronic document management systems.
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 firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and 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 CL31742 in all correspondence.