Regulatory Affairs Specialist

3 weeks ago

Slough, United Kingdom Stirling Q&R Ltd Full time

**Job Title**: Regulatory Lifecycle Specialist
**Department**: RAQA
**Reports To**: RAQA Manager

**Position Summary**:
Working under the guidance of the Quality Assurance and Regulatory Manager, the Regulatory Lifecycle Specialist will execute regulatory assurance activities, ensuring product life cycle compliance with identified regulations and standards in the UK and Ireland.

**This is a fixed-term-contract for 12-18 months.**

**Key Responsibilities**:

- Compile technical documentation and STEDs.
- Write and review device compliant documentation for EU submissions (MDR-IVDR).
- Review submission documentation for compliance with regulations, standards, and guidance.
- Manage license and registration submissions and renewals.
- Monitor submission deadlines and progress, reporting as required.
- Respond to queries from MOH bodies.
- Review significant product and process changes.
- Maintain and collate PMS / PSUR data.
- Provide Sheffield support, including data establishment and collaboration on QA documents.
- Oversee batch history sign-off, filing, and archiving.

**Competencies**:

- Proficient in processing large amounts of data with precision.
- Applies feedback for performance improvement, demonstrating accuracy and commitment to excellence.
- Achieves established goals and productivity standards.
- Adapts to new technologies, troubleshoots problems, and utilizes technology for increased productivity.
- Edits work for clarity and effectiveness.
- Accepts criticism and feedback, adapts to changes, and manages competing demands.
- Collects, researches, and synthesizes complex information.
- Maintains punctuality and attendance.

**Qualifications**:

- **Education/Experience**: Fifth-year college or university program certificate; or two to four years of related experience; or equivalent combination.
- **Language Ability**: Proficient in English, both spoken and written.
- **Mathematical Ability**: Basic mathematical operations and interpretation of data.
- **Reasoning Ability**: Solves practical problems and deals with a variety of variables.
- **Computer Skills**: Proficient in Excel, Word, SharePoint, PowerPoint.
- **Certificates and Licenses**: Qualification in Word and Excel desirable.

**Supervisory Responsibilities**: N/A

**Work Environment**: Office-based

**Physical Demands**: Some manual lifting (

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