Medical Device Compliance Specialist
5 days ago
Cure Talent is seeking an experienced Senior Regulatory Affairs Associate to join their team in West Yorkshire. As a key member of the regulatory affairs department, you will play a vital role in ensuring the company's medical devices comply with relevant regulations and standards.
Key Responsibilities:
- Develop and maintain technical files for medical devices, ensuring they meet industry standards and regulatory requirements.
- Implement post-market surveillance strategies to monitor and evaluate product performance in the market.
- Conduct internal audits to ensure ongoing compliance with MDD, MDR, and ISO 13485 standards.
Requirements and Qualifications:
- Prior experience working in the Medical Device sector with a focus on regulatory affairs.
- Strong understanding of tech file management, creation, and maintenance.
- Ability to develop and implement effective post-market surveillance strategies.
- Familiarity with MDD, MDR, and ISO 13485 standards.
Salary and Benefits: We offer a competitive salary of £55,000 - £65,000 per annum, dependent on experience, along with a range of benefits.
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