Medicareplus International Ltd
Senior Regulatory Affairs Specialist
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Senior Regulatory Affairs (RA) Specialist – Alperton
At Medicareplus International, we lead the way in advanced wound care and infection prevention, dedicated to creating innovative products that improve patient outcomes and support healthcare professionals. Our culture thrives on collaboration, innovation, and excellence. Join us and contribute to a mission that prioritises patient care and regulatory compliance.
We are seeking a Senior RA Specialist to oversee global regulatory strategies, ensuring our medical devices meet EU MDR 2017/745, ISO 13485, and other applicable standards. This role requires expert technical documentation, clinical evaluation, compliance monitoring, and cross-functional collaboration to support product registrations and regulatory submissions.
Roles & Responsibilities
Technical Documentation
- Develop and maintain Technical Documentation (UDIs, Technical File, Design History File) in compliance with ISO 13485, EU MDR 2017/745, and other global regulatory frameworks.
- Support development of labelling and marketing materials, ensuring alignment with regulatory requirements.
- Provide regulatory input on product classification, intended use, and pathways to market during device design and development.
- Draft, review, and update:
- Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) under EU MDR
- Post-market clinical follow-up (PMCF) arrangements and summaries of clinical performance
- Periodic Safety Update Reports (PSURs) and Summary of Safety and Clinical Performance (PMS PMCF)
- Collaborate with Clinical, Quality, and Marketing teams to:
- Monitor device performance and adverse event reporting
- Ensure continuous compliance with evolving regulatory standards
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Regulatory Intelligence & Compliance
- Proactively monitor regulatory updates (legislation, standards, and guidance) globally.
- Assess impact of changes and advise on implementation strategies for procedures, processes, and product documentation.
- Support vigilance and post-market surveillance (PMS) activities, including:
- Adverse event reporting (to authorities and Notified Bodies)
- Field safety corrective actions (FSCAs)
- Periodic Safety Update Reports (PSURs)
Quality System Support
- Participate in internal audits and external inspections (Notified Body, Competent Authority).
- Ensure compliance with Medical Devices Regulations (EU MDR), ISO 13485, and other Quality Management System (QMS) requirements.
- Contribute to continuous QMS improvement, particularly in areas intersecting regulatory and product risks.
Cross-Functional Collaboration
- Act as a regulatory liaison with:
- R&D teams during device development and modification
- Quality Assurance on technical documentation compliance
- Marketing for labelling and promotional compliance
- Operations for post-market strategy alignment
- Provide regulatory support during product launches, changes, and discontinuations.
Requirements
Essential
- 5+ years’ experience in regulatory affairs (RA) for medical devices, preferably in class II/III (high-risk wound care products).
- Deep expertise in:
- EU MDR 2017/745, MDR annexes XVI/XVIII
- ISO 13485:2016
- Technical documentation (Technical File, UDI, Thomas Portais, Eudamed)
- Clinical Evaluation Plans/Reports, PMCF strategies, PSURs
- Practical experience in:
- Product registration with Notified Bodies/TAs (EU, US, or other markets)
- Adverse event reporting (PVDE, IR, NCRs, etc.)
- Labelling compliance (IFU, packaging, Universally Unique Device Identifiers)
- EUDAMED database entry & maintenance
- Proven ability to:
- Compile Technical Files and Technical Documentation Files (TDF) in compliance with regulatory standards.
- Engage with regulatory authorities and Notified Bodies for inspections/audits.
- Mediate between development teams and Quality/Regulatory departments.
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Desirable
- Experience in wound care, healthcare technology, or high-risk devices.
- Familiarity with FDA (US) regulations and/or other global jurisdictions (IVDR, PRC).
- Certification in QRMP, RA software tools (e.g., MasterControl, InTEMPerature), or AIMS-based training.
- Ability to mentor junior RA team members and contribute to policy/documentation templates.
What We Offer
- Competitive salary and annual bonus scheme
- 25 days holiday (plus UK public and bank holidays)
- Company-provided smartphone and laptop
- Career development opportunities with structured Learning & Development programmes.
- Lifestyle benefits, including:
- Employee Assistance Programme (Wisdom Wellbeing) for mental health, financial, and counselling support.
- Discounts via Bright Exchange’s retail and travel partnerships.
- Online GP access via Livi for convenient healthcare.
- Team-building events and a supportive, collaborative work environment
📍 Location: Alperton Office, West London This is an exciting opportunity to drive regulatory excellence and impact innovation in healthcare. Join us and make a difference—apply now!
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