Regulatory Compliance Expert

14 hours ago


Oxford, Oxfordshire, United Kingdom Skills Alliance Full time
About Us:
Skill Alliance is a world-leading medical technology company dedicated to developing innovative solutions. We are passionate about creating high-quality products that meet the needs of our customers. As a member of our team, you will have the opportunity to work on challenging projects, collaborate with experienced professionals, and contribute to the success of our organization.

Regulatory Compliance Expert:
We are seeking a highly skilled Regulatory Compliance Expert to join our team in Oxford. As a key member of our Quality department, you will play a crucial role in ensuring the design and development of our medical devices meet the highest standards of quality and regulatory compliance. Your expertise in regulations such as cGMP, 21 CFR 820, and ISO13485 will be invaluable in ensuring that all design-related documentation meets regulatory requirements.

Job Description:
The Regulatory Compliance Expert will be responsible for ensuring that all design-related documentation meets regulatory requirements. This includes completing verification test reports, conducting risk assessments, and collaborating with cross-functional teams to identify and mitigate potential issues. The ideal candidate will have excellent communication skills, a strong attention to detail, and the ability to work effectively in a fast-paced environment.

Key Responsibilities:
  • Assure design quality through the full lifecycle process in accordance with standards and procedures.
  • Complete relevant documentation and verification test reports for devices and systems.
  • Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.

Requirements:
To be successful in this role, you will need:
  • Bachelor's degree within an engineering discipline or equivalent.
  • 3+ years of experience within quality in the medical device industry.
  • Expert knowledge of cGMP, 21 CFR 820, ISO13485, IEC 60601, and 62304.

Salary:

£60,000 - £80,000 per annum, depending on experience.



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