Regulatory Affairs Director

6 days ago

kent, United Kingdom Blackfield Associates Full time
Job Description

Blackfield Associates is seeking a seasoned professional to lead our European Regulatory Affairs team. As the Head of Regulatory Affairs and Compliance, 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.

Key Responsibilities

  • Act as the primary liaison between management and Quality, Manufacturing, and Regulatory departments to ensure seamless communication and collaboration.
  • Oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals, ensuring compliance with EU regulations.
  • Provide regulatory guidance and support, assisting in third-party audits and ensuring products meet all necessary requirements.
  • Develop and implement EU regulatory strategies, collaborating with cross-functional teams to ensure products are compliant with EU regulations.
  • Communicate regulatory impacts to the business and global partners, supporting global export registrations and ensuring regulatory compliance.
  • Manage project assignments for investigational, new, and marketed products, ensuring timely and effective delivery.
  • Collaborate with R&D and Marketing to ensure product compliance in European markets, leveraging expertise to drive business growth.
  • Liaise with government agencies and gather regulatory intelligence to stay ahead of regulatory changes and ensure compliance.

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 and proven experience in Medical Devices.
  • 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 critical to ensuring regulatory compliance and supporting the company's success in the European market. As a key member of our team, you will have the opportunity to drive business growth and make a meaningful impact on our organization.

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