Medical Device Quality and Regulatory Specialist

4 weeks ago

Gillingham, Kent, United Kingdom Henry Schein Full time
Job Title: Medical Device Quality and Regulatory Specialist

We are seeking a highly skilled and detail-oriented Medical Device Quality and Regulatory Specialist to join our team at Henry Schein. As a key member of our Quality and Regulatory team, you will play a critical role in ensuring the quality and regulatory compliance of our medical devices.

Key Responsibilities:

  • Act as the document controller for UK & IE locations defined under the shared quality management system.
  • Support the completion and publication of QMS & EMS standard operating procedures (SOPs) and work instructions (WI), ensuring that published documents are revision controlled, reviewed at defined intervals and relevant approvals are on file.
  • Maintain QMS/EMS schedules and their publication at current status; internal audit and external audit schedules, Technical Agreement and other continuous improvement lifecycle schedules.
  • Maintain, co-ordinate and follow up QMS/EMS registers and open actions for Risk Assessments, CAPAs, Deviations, Change Control and Environmental programs of work, ensuring any agreed submission/completion dates are pursued through to completion.
  • Take part in company process continual improvement initiatives, supporting in the documentation and follow-up of agreed actions.
  • Support the collation of data inputs required for the Management Review process as well as the follow up of agreed open actions.
  • Support the electronic and manual filing systems ensuring access availability of current certificates, authorizations, and records are on file.
  • Support the coordination, maintenance and update of Training Matrices.
  • Support the maintenance of the RAQA & EMS company intranet system, ensuring current versions of documentation are accessible to the Business.

Requirements:

  • Good standard of secondary education.
  • Fluent in written and spoken English.
  • Experience in document control management, preferably within a quality or environmental management system.
  • Proficient in the use of the Microsoft Office Suite of tools, with intermediate level experience of Excel desired.
  • Prior knowledge or experience of ISO9001 and/or ISO14001 is desirable but not essential.
  • Awareness of MDD93/42/EEC, and Good Distribution Practice requirements would also be desirable.

What We Offer:

  • A competitive basic salary.
  • The opportunity to earn up to 10% annual bonus based on personal and business performance.
  • 5% matched pension scheme with Scottish Widows.
  • 25 days holiday, plus public holidays.
  • Life assurance 4x basic salary.
  • A variety of flexible health & wellbeing benefits.
  • Paid time off annually to volunteer.
  • The opportunity to study and gain a suitable professional qualification.

About Henry Schein:

Henry Schein is committed to the principle of equal opportunities in employment in all spheres of its operation. We strive to operate a policy of equal opportunity and not discriminate against any person gender, race, colour, nationality, ethnic or national origin, religion, sexual orientation, marital status, disability, age or any other characteristic protected by law.

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