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Job Information

Senior Regulatory Compliance Specialist

Information About this Role

A superb opportunity for an ambitious regulatory and compliance professional to join an international leader in Medical Devices.

This is an opportunity to play a key role within a marquee organisation- enjoying huge career development and long term potential for growth with a company renowned for employee satisfaction.

Reporting into the QA & RC Manager you will enjoy a varied range of deliverables with an international focus to your work.

Job Title: Senior regulatory and Compliance Specialist

Location: South West

Contract: Permanent

Salary: Circa 45K

Benefits: Comprehensive range of corporate benefits

Responsibilities

The management and maintenance of Regulatory Compliance including:

  • Regulatory Affairs registrations coordination
  • MD Regulations and CMDR
  • CAPA and Internal Audit and Supplier Audits,
  • Compliance to ISO13485:2015, Japanese PMD Act

Your experience

  • Experience in the Quality / Regulatory arena at supervisory level or higher.
  • Must have established experience and application in the requirements of the MDD, ISO 13485 and FDA 21 CFR 820

Qualifications

  • Must have B.Sc. (Hons) degree, preferably in Science, Quality Assurance or Business Management. If not in QA, then some form of Quality Management qualification is required.
  • Must be Lead Auditor Qualified to ISO13485 (Medical Devices) at a minimum.

If this huge opportunity sounds like the one for you then do not hesitate! APPLY NOW!

For questions regarding this role please call James Powell: 02038000509.

Projectus Consulting

Projectus Consulting are a leading Medical Device Recruitment Consultancy. We are a niche business providing a highly specialist service to both employers and candidates within Medical Technology spaces.

We are passionate about finding the right role for you.