Rowland Talent Solutions are currently looking for a Senior Regulatory Affairs officer for an international Bioscience company based in London. Joining the company, you will have responsibilities for pre, and post-commercialisation activities related to product registration of In-Vitro Diagnostic products in accordance with Regulations as required for the EMEA region.
- Product Registration; compiling technical files and technical documentation to relevant authorities to support timely and efficient delivery to market
- Maintaining product submissions for products across the EMEA region, including product changes, Re-registration, Labelling updates and Translations
- Providing regulatory direction and strategy aligned to marketing plans
- Oversight of the post-market surveillance actions and communications for product feedback and improvements.
- Manage risk management files for all products in accordance with the IVDR
- Implementation and management of vigilance activities including; Recalls, Field Corrective Actions, etc.
- Manage the database.
- Sales and Marketing material review for labelling claims and compliance to harmonized and national standards, liaising with colleagues and product suppliers as required.
- Be part of the key resource group to audit distributors and product suppliers as required
- Support departments and partners as EC Representative
Ideal candidates will have a Degree in Biology or Biochemistry (Or related subject) and have expert knowledge in In-vitro Diagnostics Directive/Regulations, ISO13485 and ISO14971 standards.
To be successful in this role you will:
- Be familiar with electronic documentation systems.
- Have experience in the writing Product Submission and Technical Files, and implementing of Policies, Procedures, Work Instructions and Forms.
- Be competent in producing training programs to communicate regulatory requirements
- Have high standards of written work and good attention to detail.
- Be fluent in English and ideally Italian (desired but not essential)
- Have flexibility to travel to Italy on a regular basis (6-8 times a year for a few days each time).