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Director of Regulatory Compliance

2 months ago

Kent, United Kingdom Blackfield Associates Full time
Job Description

Blackfield Associates is seeking a seasoned professional to fill the role of Head of European Regulatory Affairs and Compliance. This position is crucial for ensuring regulatory compliance and supporting the company's success in the European market.

Key Responsibilities:
  • Regulatory Leadership: Act as the primary liaison between management and Quality, Manufacturing, and Regulatory departments, ensuring effective communication and collaboration.
  • Regulatory Strategy: Develop and implement EU regulatory strategies, ensuring products meet all necessary requirements and compliance with EU regulations.
  • Regulatory Guidance: Provide regulatory guidance and support, ensuring compliance with EU regulations, and assist in third-party audits.
  • Regulatory Intelligence: Liaise with government agencies and gather regulatory intelligence to stay up-to-date on the latest regulatory requirements.
  • Project Management: Manage project assignments for investigational, new, and marketed products, ensuring timely completion and compliance with regulatory requirements.
  • Cross-Functional Collaboration: Collaborate with R&D and Marketing to ensure product compliance in European markets, and communicate regulatory impacts to the business and global partners.
Requirements:
  • 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.
  • Communication: Excellent interpersonal, communication, and presentation skills, with the ability to effectively communicate across all levels within the company.
  • Language Skills: Fluency in a second language, ideally French.