Do you consider yourself to have strong organisation skills? Are you able to oversee product cycles from beginning to end? If so, we are looking for an individual who would be interested in joining a global medical device company as a Regulatory Affairs Specialist. You would be supporting across global patches with tasks ranging from international registration of products to impact assessments.
Role details:
Title: Regulatory Affairs Specialist
Start Date: ASAP
Pay rate: £121,000 per annum (Depending on experience)
Hours: 37.5 per week (Full Time)
Location: Remote
Main Responsibilities include:
1. Providing regulatory support for both diagnostic product development and commercial diagnostic products.
2. Performing regulatory impact assessments.
3. Develop regulatory strategies for products in development and for modified products to achieve clearance/approval internationally.
4. Providing regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
5. Research and communicate scientific and regulatory information to draft submission documents.
6. Compile and publish all material required for submissions, license renewals, and annual registrations.
7. Maintaining approvals, licenses, & authorisations for existing marketing authorisations.
8. Assess product, manufacturing, and labelling changes for regulatory reportin...