Medicareplus International
Senior Regulatory Affairs Specialist
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At Medicareplus International, we pride ourselves on being a leading force in advanced wound care and infection prevention. Our mission focuses on creating innovative products that enhance patient care and support healthcare professionals. Join us in our commitment to excellence and become part of a culture that values collaboration and innovation.
We are now looking for a Senior RA Specialist to plan, prepare, and coordinate regulatory activities to ensure that the company’s medical devices comply with applicable global regulations, standards, and internal policies. The Senior RA Specialist will support product registrations, the compilation and upkeep of technical documentation, clinical evaluations, labelling compliance, and interactions with regulatory authorities and Notified Bodies.
Roles and Responsibilities
Technical Documentation
- Develop and maintain Technical Documentation in line with ISO 13485, the Medical Device Regulation 2017/745 (EU MDR) and other applicable regulatory requirements.
- Support the creation and review of labelling and marketing materials to ensure compliance with relevant regulations.
- Participate in design and development projects to provide regulatory input on classification, intended use, and regulatory pathways.
- Develop and maintain Clinical Evaluation Plans and reports in accordance with EU MDR
- Coordinate the collection and analysis of clinical data, literature reviews, and post-market clinical follow-up activities.
- Support the preparation of Periodic Safety Update Reports and Summary of Safety and Clinical Performance where applicable.
- Collaborate with Clinical, Quality and Marketing teams to monitor and report on device performance and safety.
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Regulatory Intelligence and Compliance
- Monitor changes to applicable legislation, standards, and guidance, assess and communicate impact in line with the procedures.
- Support implementation of regulatory updates into procedures, processes, and product documentation.
Quality System Support
- Participate in internal and external audits, including Notified Body and Competent Authority inspections.
- Support vigilance and post-market surveillance activities, including adverse event reporting, field safety corrective actions, and periodic safety update reports.
- Assist in maintaining and improving the Quality Management System where it intersects with regulatory requirements.
Cross-Functional Collaboration
- Liaise with Medicareplus SMEs, Quality Assurance, Clinical, Marketing and Operations, teams to ensure alignment of regulatory strategies with business objectives.
- Provide regulatory and clinical support during product launches, changes, or discontinuations.
Experience
- 5+ years in the medical device industry in a similar Regulatory role.
- Strong knowledge of EU MDR 2017/745, ISO 13485, and other relevant international regulatory frameworks and standards.
- Proven ability to compile, maintain, and submit Technical Documentation, product registrations, and regulatory submissions to authorities and Notified Bodies.
- Experienced in clinical evaluation activities, including Clinical Evaluation Plans/Reports, literature reviews, and post-market clinical follow-up.
- Solid understanding of labelling compliance, product classification, intended use determination, and regulatory pathways during product development.
- Skilled in post-market surveillance and vigilance activities, including adverse event reporting, PSURs, and field safety corrective actions.
- Strong, pragmatic collaborator across Quality, Clinical, Marketing, R&D, and Operations, supporting product launches and ongoing compliance.
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WHAT WE OFFER:
- Competitive salary and bonus
- 25 days holiday + public/bank holiday
- Mobile phone and laptop
- Learning & Development - We encourage professional development and progression for all our team
- Lifestyle Benefits: Our Employee Assistance Programme offers a range of services including financial, wellbeing and counselling via Wisdom Wellbeing. A range of discounts are offered via Bright Exchange
- Online GP Services - Access to an online GP service via Livi
- Team building events
Based in our Alperton office, this role is your chance to join a collaborative, supportive team of experts. If you want to work together to make a real difference, apply now!
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