Regulatory Affairs Director

4 days ago

kent, United Kingdom Blackfield Associates Full time
Job Title: Senior Manager Regulatory Affairs

Blackfield Associates is seeking a highly skilled Senior Manager, European Regulatory Affairs, to lead the company's regulatory efforts across Europe. This role will ensure all regulatory and compliance activities are effectively managed, supporting the distribution, R&D, and marketing of products.

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.
Requirements:
  • Educated to degree level in a relevant scientific field.
  • More than 7.5 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.
  • Essential: EU regulatory experience, including MDR and MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001).
  • This position will have direct reports; successful candidates will be able to demonstrate previous leadership experience.
  • Project Management: Ability to manage multiple projects, work cross-functionally, and deliver on business goals.
  • Auditing: Due to portfolio size, only candidates who have extensive, hands on experience with either leading audits, or being 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.

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