Mantell Associates is partnered with a rapidly growing Medical Device CRO, who is looking to expand their team with the addition of a Director of Regulatory Affairs (IVD).
You will play a central role in ensuring the consumer healthcare brands owned by the company meets international regulatory requirements in the markets in which it operates. The RA Director will help lead this function, with particular focus on ensuring product compliance in France, Germany & the UK, Canadian and EU markets, and will report directly to the leadership team.
Director of Regulatory Affairs (IVD) - Responsibilities:
Develop and implement effective Regulatory strategies by maintaining Policy and Intelligence
Mentor a team of regulatory professionals, providing guidance and leadership to ensure adherence to global regulations and internal policies
Be at the forefront of new and developing regulations and guidelines
Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval
Provide an overview of RA Policy to stakeholders and staff
Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations
Ensure submission publishing is well executed and on time
Engage relevant staff to support M&A activities
Manage a Regulatory Affairs network externally and internally
Director of Regulatory Affairs (IVD) - Requirements:
Bachelor's or advanced degree in a scientific or medical field
Strong experience within Regulatory Affairs in the Biotech / Pharmaceutical space, including leadership experience
Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval
Strong leadership and management skills, with the ability to mentor and develop a team of regulatory professionals
Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders
Proven track record of Global Regulatory Processes
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.