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QA Manager- Medical Devices

Job Title: QA Manager- Medical Devices
Contract Type: Permanent
Location: Watford, Hertfordshire
Industry:
Salary: Negotiable
Reference: J900174_1557740287
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: May 13, 2019 10:38

Job Description

RA/Regulatory Affairs Manager, Medical Devices

Type: Permanent

Location: North London

Salary: Competitive, includes bonus and additional benefits

Hours: Days

Our Client, a major Medical Devices company who are experiencing significant growth at this time; are looking to appoint an experienced RA Manager. This RA Manager will have exceptional people management experience and be able to support and mentor the existing team; whilst driving continued results.

Reporting to the Quality Director:

The RA is responsible for all aspects of pre and post-market regulatory compliance. This involves maintaining an awareness of regulatory requirements, advising the business on regulatory topics; supporting the NPD pipeline; ensuring market access and handling post-market regulatory issues.

  • Deputise for RA/QA Director on regulatory topics
  • Management Responsibilities
  • Maintaining an awareness and ensure compliance with relevant regulations and laws in all markets.
  • Clarify regulatory roles within projects and manage registration requests / priorities.
  • Follow up and escalate issues
  • Respond to enquiries from all stakeholders (including regulators; trade bodies; government bodies)
  • Oversee NPD projects and progress of product registrations
  • Identify and scope out new regulatory projects (timelines/ costs)
  • Provide advice on quality and regulatory requirements to key stakeholders as appropriate.
  • Select, monitor and manage external regulatory consultants
  • Manage and support Regulatory Specialists to achieve their responsibilities and objectives.
  • Overall responsibility for project progress and compliance of product areas within scope of role

The Person:

  • Will hold a degree in a relevant, Scientific/ technical discipline.
  • Strong people management experience in a relevant RA Manager setting (Conflict resolution, coaching, staff management etc).
  • Broad knowledge of regulatory requirements for medical devices including registration, manufacturing and post market controls
  • Extensive experience of working with ISO13485
  • Experience with Risk management (ISO14971
  • The perfect person will have Microbiology / awareness of infection control too.

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