Senior Regulatory Affairs Associate
Oliver Care is recruiting for a Senior Regulatory Affairs Associate to join a company in the Medical Device industry at their site based on the outskirts of Glasgow on a permanent basis.
The main purpose of the role will be to:
- Prepare regulatory documentation and submissions for product approvals as well as producing and reviewing design dossiers, technical files and device master files.
- Develop regulatory strategies and plans for new products as well as changes to existing products and provide regulatory input to functional groups as required.
- Take-part in design control, risk management and post market surveillance activities.
Further responsibilities will include:
- Preparation and review of Regulatory documents in line with international standards and new regulations and the review of Regulatory Affairs procedures.
- Review product packaging, labelling, IFUs and marketing literature to ensure compliance with country specific regulations.
- Act in an advisory capacity across the business and share knowledge and help mentor and develop other 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 relevant field with additional regulatory experience in the medical device or pharmaceutical industry.
- Experience of making regulatory business decision for new products or existing product changes and experience of EU/US submissions and working with regulatory bodies.
- Excellent attention to detail and organisational skills with experience of MS Office applications.
This is an excellent opportunity to join an innovative and expanding medical device manufacturer with an exciting and wide ranging product portfolio.
An attractive benefits package is offered with this role.
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 CL31103 in all correspondence.