Description
One of the world's most successful bio-techs has recently been through large year on year revenue growth and is now recruiting for a Senior Regulatory Manager;General Responsibilities;
- Ensuring Compliance with Global Regulatory Requirements
- Participation in project teams to provide regulatory input into cross departmental international registration projects.
- Preparation of documentation in order to support global Regulatory Submission.
- Review and approval of labelling, advertising and promotional materials in order to ensure regulatory compliance.
- Supporting Post Marketing activities(i.e. Surveillance, vigilance, annual reports).
Desired Requirements.
- Minimum Degree (or equivalent) in a scientific field.
- Minimum of 5 years experience in a similar role in the Medical Device Industry. Preferably in the In Vitro Diagnostics industry.
- Experience of FDA/Canadian regulatory bodies would be preferential.
- Excellent working knowledge of the EU MDD and IVDD.
Personal Requirements.
- Good interpersonal skills and communication skills.
- Ability to handle multiple projects simultaneously.
- Ability to work with minimal supervision.
The client has a flexible budget for the right candidate so. If you are interested in hearing more about this role then please send me an up to date copy of your CV and I will be in touch shortly as they are currently short listing profiles.
Sthree UK is acting as an Employment Agency in relation to this vacancy.