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Regulatory Affairs Director

2 months ago

Kent, United Kingdom Blackfield Associates Full time
European Regulatory Affairs Manager

Blackfield Associates is seeking a highly skilled European Regulatory Affairs Manager to lead our regulatory efforts in the European market.

Key Responsibilities:

  • Develop and implement EU regulatory strategies to ensure compliance with EU regulations.
  • Provide regulatory guidance and support to ensure compliance with EU regulations.
  • Manage technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
  • Liaise with government agencies and gather regulatory intelligence.
  • Collaborate with R&D and Marketing to ensure product compliance in European markets.

Requirements:

  • 5 years' experience in regulatory affairs, ideally gained within a Medical device/ consumer goods business.
  • Proven experience in Medical Devices is essential, plus experience in an additional sector such as Cosmetics and/or Pharmaceuticals will be considered/ preferable.
  • EU regulatory experience, including MDR and MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO).
  • Project Management: Ability to manage multiple projects, work cross-functionally, and deliver on business goals.
  • Auditing: Extensive, hands-on experience with leading audits, or being a key point of contact for audits and inspections by regulatory bodies.
  • 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.