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Regulatory Affairs Officer
2 weeks ago
**Title**: Regulatory Affairs Officer
**Salary**: c. £25,000 - £30,000
**Location**: Newcastle-Upon-Tyne
**Contract**: Permanent
Do you have a passion for Medical Devices, with a high attention to detail and an interest in regulations? An exciting new opportunity with a rapidly expanding Medical Device company based in Newcastle-upon-Tyne is now available The company look to hire an individual aligned with their goal of advancing diagnostics.
As a **Regulatory Affairs Officer**, you will support with tasks regarding site regulatory obligations by following established procedures, policies and working instructions. You will support in areas such as submissions, device listings, site licences, registrations, and compliance, reporting directly to Senior RA Officer/Manager. You will be able to work to your own initiative to solve complex problems and tasks.
Main Responsibilities:
- Support submissions, registrations, device listings, site licenses via:
- Working with global colleagues.
- Establish and maintain official site regulatory files, device listings and licenses according to government expectations and company procedures.
- Ensure Technical File documentation is made available to the Global Registration Team, Distributors and others as required with subsequent compiling of additional technical documents/letters to support country specific registration requirements.
- Support Sr. RA Officer(s), RA management in introducing new regulations.
- Support site change control process, ensuring Technical Files are managed and contemporary.
- Serve as site RA representative on change management initiatives.
- Support compliance via:
- Reviewing of labelling, advertising, and promotional material for compliance to approved product claims and necessary regulations.
- Documentation of regulatory strategies.
- Site Support via:
- Use business system regularly to continuously improve RA function.
- Support any departmental CAPA or non-conformance activities.
- Help directly with all audit requirements.
- Establish and maintain effective working relationships with RA colleagues.
- Maintain an up-to-date working knowledge of all relevant regulations.
About You:
- Relevant scientific or technical degree. Further working knowledge in Medical Devices or IVD preferred.
- Ability to effectively manage time and organisational skills.
- Contemporary and extensive working knowledge of relevant regulations.
- Ability to work effectively in a team/with others as well as the ability to work to your own initiative.
