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Head of Quality and Regulatory Affairs

3 months ago

Crawley, West Sussex, United Kingdom Evolve Selection Ltd Full time

Our client is looking for a Head of Quality and Regulatory Affairs to successfully lead and design the execution of the regulatory affairs and quality assurance strategy to ensure the business is compliant and to ensure product quality and customer satisfactionacross the whole of the organisation.

This is a fantastic opportunity for an inspirational leader to manage a successful team in a leading player in the global Medical Device marketplace.

This is a full time remote based position.

Ideal Requirements

  • Qualification in Quality and Regulatory Affairs.
  • At least 8 years' experience in Quality and Regulatory environment in the following areas: medicinal, medical, cosmetic and food supplement.
  • GMP and/or GDP experience is essential.
  • Excellent knowledge of ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions.
  • Experience dealing with Notified Bodies relating to Medical Devices.

Role Responsibilities

  • Provide technical leadership and vision through the interpretation of new and emerging international regulatory trends pertinent to local business needs and develop and implement strategies and projects to optimize regulatory performance.
  • Work closely with the New Product Development Team to offer input on the Quality and Regulatory aspects of the future product pipeline.
  • Plans, prioritises and monitors activities and resources of the team based on business needs.
  • Lead the companies Quality Management Systems including Documentation, Complaints Management, CAPA and Management Review.
  • Provide regulatory advice and perform regulatory assessments of business development opportunities.

Role Specific Competencies

  • Excellent communication and interpersonal skills.
  • Strong skills in planning and organising work.
  • Ability to work in a fastpaced environment.
  • Selfmotivated

Recruitment Process

  • 2/3 stage process.
Evolve is a leading recruitment and outsourcing organisation, operating within the Pharmaceutical, Healthcare, Medical Device and Life Science sectors.