This Senior Regulatory Affairs Specialist job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in Inverness, Scotland. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.
This regulatory affairs role will support the RA Project Leads for new blood glucose monitoring system development projects.
Responsibilities will include:
- Supporting the project RA Lead during characterization, verification & validation, labelling & claims development.
- Assisting in preparation of pre-market applications to regulatory agencies.
- Researching, consolidating and communicating global regulatory requirements to enable development of global regulatory strategies.
- Partnering with global regulatory affiliates and providing documentation to support international applications for new products/maintenance of existing product licenses.
- Assisting in the development of best practices for Regulatory Affairs processes
- Demonstrated experience working in a Regulatory Affairs role within the medical device industry
- Degree qualified, preferably in a scientific or technical field
- Familiarity with medical device regulations in US and/or EU
- Excellent verbal and written communication skills
- Strong organizational, interpersonal, and problem solving skills; detail oriented
- Ability to work independently and collaboratively with minimal supervision
- Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and electronic document management systems.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.