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Form of workJob Description
Cure Talent is delighted to partner with a rapidly growing MedTech Design House based in Glasgow. This innovative company specialises in the design and development of a wide array of Medical Devices, partnering with providers to develop revolutionary solutions. Due to their continued, exceptional growth, we are seeking a Risk Management Specialist to join their dynamic team.
The ideal candidate will possess in-depth knowledge and understanding of Medical Device Risk Management, Quality Systems, Regulations and Design Control processes. The Risk Management Specialist will play a crucial role in defining and developing Risk strategies for both new and existing products, compliance with global medical device regulations, including MDR and ISO 13485 and will actively contribute to the success of the multi-disciplinary device design teams.
Responsibilities:
- Champion Risk Management, including strategy, for new and existing products, working closely with the Design teams.
- Spearhead Risk Management Initiatives for the full product lifecycle.
- Lead and participate in design control activities, including user needs analysis, design input writing, and Risk Management to ISO 14971.
- Write, review, and maintain design documentation for inclusion in Design History Files (DHF) and Technical Files (TF).
- Contribute to Design Verification/Validation activities, ensuring products meet design and quality requirements.
Qualifications:
- Bachelor's degree in a relevant scientific or engineering discipline.
- Proven experience in Risk Management for new and existing products, including the implementation of Regulatory Strategies.
- Proven experience in medical device quality assurance and regulatory affairs.
- Thorough understanding of MDR, ISO 13485 and ISO 14971.
Preferred Skills:
- Experience with design control processes and documentation.
- Familiarity with international medical device regulations.
- Certification in regulatory affairs or quality management (e.g., RAC, CQM).
If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!
