Regulatory Associate – Medical Devices
Join an innovative and fast-paced medical device company dedicated to delivering high-quality products that improve patient outcomes. This role offers an exciting opportunity to be part of a collaborative RA/QA team, driving global compliance and regulatory strategy execution. If you are motivated by autonomy, responsibility, and making a tangible impact on patient safety, this position will enable you to advance your regulatory career in a dynamic and meaningful environment.
Key Responsibilities:
Regulatory Submissions: Prepare, submit, and maintain global regulatory submissions and renewals across key territories.
Compliance Management: Compile and maintain MDR-compliant Technical Files, ensuring a smooth transition from MDD to MDR formats.
Stakeholder Support: Provide regulatory guidance to external distributors, authorised representatives, and internal teams.
Post-Market Activities: Manage post-market surveillance, clinical evaluation maintenance, and complaint trend analysis, ensuring accurate reporting.
Regulatory Intelligence: Monitor global regulatory changes, interpreting their impact and advising senior management.
Audit Preparation: Participate in external audits (e.g., Notified Bodies) and lead internal audit coordination.
Product & Process Review: Review and approve product, labelling, and process changes for regulatory compliance.
Liaison & Coordination: Engage with Notified Bodies to facilitate technical file reviews and audits.
Qualifications & Experience:
Education: Degree (2:1 or above) in a scientific or engineering discipline.
Medical Device Expertise: Proven experience working within 93/42/EEC and MDR 2017/745 frameworks.
Standards Knowledge: Strong understanding of CE Marking, ISO 13485, ISO 14971, GMP, and ISO 15223.
Technical File Management: Skilled in authoring and maintaining Declarations of Conformity and Technical Files.
Audit Experience: Experienced in liaising with Notified Bodies and supporting external and internal audits.
Professional Skills: Highly organised, detail-oriented, and commercially aware, with excellent communication, analytical, and problem-solving abilities.
Work Approach: Able to work both independently and as part of cross-functional teams.
Why Join Us?
This is an opportunity to contribute to the delivery of life-enhancing medical devices to patients worldwide. You will play a pivotal role in shaping compliance processes, influencing product success, and ensuring continued access to safe and effective medical technologies.
If you are ready to take the next step in your regulatory career, please submit your CV and a brief cover note outlining your suitability. For a confidential discussion, get in touch directly.
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