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Head of Regulatory Affairs

Added on:
15 Feb 2019
Reference:
1704-2
Location:
Kent
Base Salary:
60000

Description

Head of Regulatory Affairs required for the Medical Device Division

Reporting to the Technical Director and working in a highly conducive and newly constructed environment, the Head of Regulatory Affairs will be responsible for identifying, implementing and maintaining regulatory requirements for all existing and future needs of the business as relates to the Medical Device Division

ROLE

  • Provision of advice, guidance and support to the highly successful and rapidly expanding Medical Device Division
  • Working under ISO13485, ISO9001, ISO14971, CMDCAS and FDA CFR 21 part 820
  • Managing the regulatory affairs department and ensuring regulatory compliance for all manufactured medical products
  • Liaising directly with all applicable Notified Bodies and Government Agencies for Medical and IVD manufactured goods to ensure the required country specific elements are met
  • Managing technical file creation, 510(k) submissions, all product registrations and International compliance
  • Overseeing all regulatory aspects from design through manufacture including risk management and validation
  • Creating and managing Technical Agreements and Quality/Regulatory agreements with customers, ensuring that both Regulatory and Legal aspects are covered and agreed.

REQUIRED

Appropriate qualifications with a minimum of 3-5 years of experience of operating in a similar role within the Medical Device sector

REMUNERATION

Excellent salary with supporting benefits package

RESPOND

To learn more about this role, Telephone Terry Blaney on 01580 211221 or E-mail your Application to terry@arxconsultancy.com