October 30th 2024

Clinical Affairs Director

Job description

We are currently working with a Sweden-headquartered medical device business that focuses on biotechnological manufacturing methods and the promotion of cutting-edge and forward-looking biomaterials. With strong R&D resources, the company are poised to expand into multiple lines of medical device products covering fields such as aesthetics and plastic surgery. Due to their continued growth, they are now looking for a Clinical Affairs Director to join their team.

As a Clinical Affairs Director, you will be responsible for shaping and leading clinical strategies that enable global market access. In this role, the Clinical Affairs Director will provide essential medical and scientific support to ensure the safety and effectiveness of the company's medical device products. Collaborating closely with R&D, Regulatory Affairs, and Medical Affairs teams and reporting directly to the CEO, this leader will play a key role in driving the company’s mission as a global leader in anti-ageing solutions.

Key responsibilities:

• Lead and manage Clinical Affairs strategy, focusing on global regulatory submissions and product approvals.
• Develop and oversee clinical studies, collaborating with Regulatory Affairs to support product approvals.
• Conduct literature reviews on company products and competitors, staying updated on regulatory guidelines and industry standards.
• Oversee clinical study management to produce scientific publications and contribute to R&D strategies for new product development.

To be considered for the role, you must closely match the following criteria:

• Extensive experience in medical affairs, scientific communications, or clinical research in the medical device industry, particularly with injectable Class III devices and preferably within the medical Aesthetic or Regenerative Medicine industries.
• Skilled in managing clinical documentation and applications, with expertise in both US FDA applications and European registrations (EMA or notified body).
• Proficient in interpreting and presenting scientific data to diverse audiences, with a strong understanding of drug and medical device development and regulatory processes.
• Holds an advanced degree (MD, PhD, PharmD, or equivalent) in a relevant scientific field.

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