Department: Regulatory Affairs
Reporting: QA/RA Manager
The Regulatory Affairs Specialist is responsible for supporting regulatory affairs activities including preparation of regulatory filings, interactions with regulatory bodies, regulatory decision making in relation to changes and post market data. The role requires a minimum of 3 years Regulatory Affairs experience in the medical device industry and the candidate must exhibit excellent communication skills with the ability to communicate in writing clearly and professionally to regulatory bodies. The RA Specialist shall be knowledgeable in requirements for premarket clearance of medical devices in the USA. As a member of a growing team the Regulatory Affairs Specialist must be flexible and willing to carry out tasks outside of their routine responsibilities.
DUTIES & RESPONSIBILITIES
The role of the Regulatory Affairs Specialist includes but is not limited to the following responsibilities and skill sets:
- Support the development and submission of high-quality regulatory filings to the relevant regulatory agencies, IRBs, and ethics committees, and managing the submission process through to successful approval/clearance.
- Developing regulatory strategies for new products/product changes.
- Co-ordinate and, where appropriate, conduct change assessments to evaluate and document the impact of product changes to regulatory filings.
- Keep up to date with changes in applicable regulatory requirements and standards
- Assist company preparation for inspection by regulatory authorities (e.g., notified bodies, FDA etc)
- Co-ordinate and progress post-market Adverse Event reporting to regulatory authorities
- Ensuring adherence to all organisational and external regulatory requirements
- Degree in Science or related disciplines,
- Minimum of 3 years experience in Regulatory Affairs,
- Experience of preparing documentation for submission to regulatory agencies and interacting with regulatory bodies,
- Experience working in a regulatory role within medical devices,
- Working knowledge of
- FDA QSR,
- FDA 510k
- FDA Medical Device Reporting
- ISO 13485
- Excellent communication, organisational and time management skills
- Excellent writing skills with ability to clearly communicate in writing.