Regulatory Compliance Expert

1 month ago


Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time

We are 52North, creators of Neutrocheck®, a med-tech company striving to transform patient experiences and set new industry standards through innovative technology.

This exciting opportunity requires a Regulatory Compliance Expert to oversee our QMS, ensure adherence to regulations, and develop effective quality processes.

Responsibilities
  • Leading the development and implementation of quality policies and procedures to meet regulatory requirements
  • Maintaining accurate and up-to-date records, ensuring compliance with industry standards and regulations
  • Collaborating with cross-functional teams to resolve quality-related issues and improve overall performance
  • Providing training and guidance to colleagues on quality processes and best practices

The ideal candidate will possess strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to work effectively in a fast-paced environment.

The estimated annual salary for this role is around $90,000 - $125,000, based on experience and qualifications.

Requirements
  • Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline
  • At least 3 years' experience working in an ISO13485-certified quality management system for devices that require review and approval by authorities
  • Strong knowledge of regulatory requirements and industry standards

We offer a competitive benefits package, including a hybrid working arrangement, flexible schedule, generous holiday allowance, maternity, paternity, and adoption policies, EMI share option scheme, pension scheme, health insurance, dental and optical coverage, wellbeing engagement programme, and office perks.



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