Head of Regulatory Affairs

View more Jobs by
x4 Group
Reference
JF0211
Sector
Scientific
Salary
£69,500 to £70,000 Per Annum
Location
Cheshire
Job Type
Permanent/Full Time
Date Posted
2nd November 2017

Job Description

Overall Job Purpose:

  • To ensure all products meet the relevant global regulatory requirements.
  • To obtain and maintain required regulatory authority approvals, authorizations and clearances.
    • Provide company Regulatory strategy in line with overall company strategy.
    • To be the official correspondent/primary point of contact for regulatory authorities.
    • Provide leadership to the Regulatory Affairs department.

 

Key Responsibilities

  • Provide project-specific Regulatory strategy to ensure a timely route to market.
  • Prepare regulatory submissions where required and secure timely approvals.
  • Liaising and negotiating with regulatory authorities.
  • Maintain up-to-date knowledge of regulatory legislation, guidelines etc.
  • Ensure the maintenance of all Standard Operating Procedures in line with current legislation, regulatory authority guidance and best practice.
  • Develop and implement plans to achieve department goals and strategies.
  • Represent Regulatory Affairs in project teams providing strategic advice on technical, pre-clinical, clinical matters, and the regulatory pathway for development of products.
  • Lead project teams as necessary for the resolution of Regulatory issues. 
  • Review product labeling for all product claims, ensuring supporting data is on file.
  • Review product and process change requests ensuring compliance with all relevant regulations.
  • Ensure the maintenance of all regulatory technical documentation such as Technical Files, Design Dossiers and 510(k)s.

Key General Responsibilities

  • Lead the Regulatory Affairs department and strategy towards achievement of corporate goals.
  • To control and manage the department budget and performance.
  • Monthly reporting of KPIs (key performance indicators).

Experience

  • Must have experience in Regulatory submissions to the US including 510K and combination products, experience with PMA’s would be an advantage, submissions to the EU including Class 1IIa, IIb and Class III
  • Experience in leading a team with demonstrable process and project management to achieve targeted goals
  • Experience of Medical Device registration s for global markets including Canada, Brazil, Australia, Middle and Far East would be an advantage

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