I am currently recruiting 2x Senior Regulatory Affairs Executives to join a global medical device company based near Glasgow.
- Preparation of regulatory documentation and submissions for product approvals.
- Development of regulatory plans/strategies for new products and changes to existing products
- Participation in Design Control, Risk Management and Post Market Surveillance activities
- Production and review of design dossiers, technical files and change assessments
- Review and preparation of regulatory paperwork in accordance with International standards and new regulations
- Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations
- Facilitate compliance with Vigilance System.
- Provide regulatory input to functional groups as required
- Participate in review of RA procedures
- Other duties as required by RA department..
The Successful Candidate
- Will be degree qualified in a technical life science related discipline. (Biochemistry, Chemistry, Biomedical, microbiology or related discipline).
- You will also have experience in Quality Assurance or Regulatory affairs ideally from a medical device background.
These positions are immediately available and offer fantastic career progression prospects.
Please apply online or for more information, please call Paul on 0161 942 4035