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European Compliance Specialist

2 months ago

Kent, United Kingdom Blackfield Associates Full time

Blackfield Associates is seeking a seasoned professional to lead our European Regulatory Affairs team. As the Head of Regulatory Strategy, you will be responsible for ensuring all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of our products.

This role will lead the European Regulatory Affairs team, partner with our European business, and liaise with Quality Leadership on regulatory matters. As the primary liaison between UK/EU management and Quality, Manufacturing, and Regulatory departments, you will oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.

Key Responsibilities:

  • 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:

  • Minimum of a Bachelor's degree in life sciences, medical, or a related field.
  • 8+ years of experience in regulatory affairs, with a focus on the European market.
  • Proven experience in Medical Devices is essential, plus experience in an additional sector such as Cosmetics and/or Pharmaceuticals.

Desirable Skills:

  • In-depth knowledge of EU regulations, including MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO).
  • Strong leadership skills with a results-oriented and business-focused approach.
  • Ability to manage multiple projects, work cross-functionally, and deliver on business goals.
  • Experience in dealing with regulatory authorities and working within a matrix organization.
  • Fluency in a second language, ideally French.

This role is crucial for ensuring regulatory compliance and supporting our company's success in the European market. There will be travel to affiliate sites in Europe several times per year.