Compliance & Regulation Manager

Posted 10 April by Zebra Consultancy

The role of Regulatory Affairs Manager is a new position for my client, based in their prestigious offices in Newcastle, Staffs, providing a management resource for regulatory activities.

Key Responsibilities:

  • Reporting to the Compliance Director on all matters pertaining to regulatory activities in order to perform and maintain a regulatory management role independent of the purchasing, manufacturing and testing functions
  • Identifying, registering and maintaining my client’s site and product registration in accordance with specified country requirements
  • Assessing the impact of design changes for regulatory compliance and the implications for maintaining product registration
  • Authority to control further processing or delivery of non-confirming product until the non-conformity is resolved
  • Authority to release product on concession if regulatory requirements are met
  • Promoting awareness to staff on meeting customer, quality and regulatory requirements
  • Reporting the implications of regulatory changes to management Review
  • Providing a resource for quality audits
  • Providing general support for activities falling under the remit of the Compliance Director

Key skills and attributes:

  • Previous regulatory and/or quality experience within a medical regulated industry would be an advantage
  • Task focused and able to work within a team
  • Must be able to manage own workloads
  • Understanding of medical device regulation and its application
  • Excellent record keeping and documentation maintenance
  • Educated to degree level (or equivalent) in a science based subject or relevant experience
  • Ability to focus colleagues on departmental and company objectives
  • Organised and structured approach to task management
  • Good communicator, both verbally and in written form
  • Customer focused
  • Computer literate - MS Office
  • Willing to learn new skills

Full driving licence required

Hours of work: Mon - Fri, 9.00am - 5.00pm

Holidays: 20 days + bank holidays

Job Types: Full-time, Permanent

Required experience:

  • Regulatory Affairs & Compliance: 1 year

Required skills

  • Medical Devices
  • Regulatory Affairs
  • Compliance Procedures
  • Quality Auditing
  • product registration

Application question

Do you have at least 12 months experience in this type of role?

Reference: 34284846

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