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Head of Regulatory Affairs

2 months ago

Kent, United Kingdom Blackfield Associates Full time

Blackfied are pleased to be partnered with an international business, with a requirement for a Head of European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team, partners with the European business, and liaises with Quality Leadership on regulatory matters.

Key Responsibilities :

  • Act as the primary liaison between UK/EU management and Quality, Manufacturing, and Regulatory departments.
  • Oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
  • Provide regulatory guidance and support, ensuring compliance with EU regulations, and assist in third-party audits.
  • Develop and implement EU regulatory strategies, ensuring products meet all necessary requirements.
  • Communicate regulatory impacts to the business and global partners, supporting global export registrations.
  • Manage project assignments for investigational, new, and marketed products.
  • Collaborate with R&D and Marketing to ensure product compliance in European markets.
  • Liaise with government agencies and gather regulatory intelligence.

Skills & Knowledge Required :

  • Education : Minimum of a Bachelor's degree in life sciences, medical, or a related field.
  • Experience : 8+ years in regulatory affairs, with a focus on the European market.
  • Sector Knowledge : Proven experience in Medical Devices is essential, plus experience in an additional sector such as Cosmetics and/or Pharmaceuticals.
  • Regulatory Expertise : In-depth knowledge of EU regulations, including MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001).
  • Leadership : Strong leadership skills with a results-oriented and business-focused approach.
  • Project Management : Ability to manage multiple projects, work cross-functionally, and deliver on business goals.
  • Communication : Excellent interpersonal, communication, and presentation skills, with the ability to effectively communicate across all levels within the company.
  • Regulatory Interaction : Experience in dealing with regulatory authorities and working within a matrix organization.
  • Language Skills : Fluency in a second language, ideally French

This role is crucial for ensuring regulatory compliance and supporting the company's success in the European market.

There will be travel to affiliate sites in Europe several times per year.