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Job Title: Senior Regulatory Affairs Associate
Location: Flexible / Remote
Competitive Salary + Benefits
Are you an experienced Regulatory Affairs professional with a solid understanding of EU MDR and global medical device regulations? We are recruiting a Senior Regulatory Affairs Associate to join a forward-thinking medical device organization. This role is essential in ensuring regulatory compliance across the product lifecycle, supporting market expansion, and driving successful regulatory submissions and approvals.
The ideal candidate will bring technical expertise, attention to detail, and the ability to collaborate with cross-functional teams to maintain compliance and support product innovation.
Key Responsibilities:
- Regulatory Submissions: Prepare and submit regulatory documentation for new products, modifications, and renewals, including CE Marking, 510(k), PMA, and international submissions.
- Regulatory Strategy: Develop and implement strategies for timely approvals, aligning with both U.S. and international requirements.
- Regulatory Compliance: Maintain compliance with medical device regulations, standards, and guidance documents throughout the product lifecycle. Stay updated on emerging regulatory changes and communicate key impacts.
- Quality System Support: Collaborate with Quality Assurance to ensure compliance with ISO 13485, 21 CFR Part 820, and other standards. Support audits, inspections, and CAPA processes.
- Technical Documentation: Prepare, maintain, and update technical files, Design Dossiers, and Device Master Files to meet global market requirements.
- Post-Market Surveillance: Support post-market surveillance activities, including adverse event reporting, corrective actions, and recalls.
- Risk Management: Assist in risk assessments and ensure they are appropriately documented and incorporated into submissions.
- Cross-Functional Collaboration: Partner with teams across R&D, Quality, Clinical Affairs, and Marketing to integrate regulatory requirements into product development.
- Training & Development: Provide training to junior team members and other business functions on regulatory and quality practices.
Qualifications and Experience:
- Education: Bachelors degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or related field.
- Experience: Approximately 3 years of experience in Regulatory Affairs within the medical device industry, with a focus on EU MDR compliance.
- Knowledge: In-depth understanding of EU MDR, ISO 13485, and other international regulations (e.g., FDA, Health Canada, TGA).
- Skills:
- Proven expertise in preparing and submitting regulatory filings.
- Strong project management skills and ability to handle multiple priorities.
- Exceptional written and verbal communication skills, with excellent attention to detail.
- Proficiency in regulatory documentation tools and software.
- Other Requirements: Full UK driving licence and flexibility to travel as needed.
Why Join Us?
This is a unique opportunity to play a vital role in a dynamic and innovative organization. If you are passionate about regulatory compliance, enjoy working in a collaborative environment, and are ready to make a significant impact, we want to hear from you.
Apply today to explore this exciting career opportunity!
