Job description

Clinical Development & Affairs Manager EMEA

Location: Europe (Germany, Netherlands, Spain, United Kingdom)

We are seeking a Clinical Development and Affairs Manager to enhance our EMEA Operating Model for Medical and Scientific Affairs. This role focuses on supporting evidence generation studies, reports, and documentation to maintain regulatory-approved claims and meet market needs, with an emphasis on CE-IVDR requirements. The position involves close collaboration with Medical and Scientific Affairs, Regulatory Affairs, and Clinical Affairs, and requires practical knowledge of regulatory requirements to manage and execute studies and reports effectively.

What you expect:

You will be required to design studies to maintain claims in EMEA, focusing on CE-IVDR.
Providing protocol development support for regional/local studies in line with regulatory standards.
Collaboration with R&D, Regulatory Affairs, and Clinical Affairs.
Bridging regional requirements with Hologic's global functions to ensure seamless communication and alignment, particularly for EU regulatory clearance and commercialization.
You will be expected to maintain a understanding of ongoing clinical trials in the region.
Stay updated on EU (CE-IVDR) and country-specific regulatory requirements (e.g., UKCA), clinical trial guidelines, industry standards, and ethical guidelines.
Develop and maintain SOPs.

What we expect:

Knowledge of clinical development processes, including study design, protocol development, and study monitoring.
Familiarity with regulatory requirements (CE-IVDR, UKCA, ISO standards), QMS, and GCP guidelines.
Expertise in in-vitro diagnostic technologies and proficiency in medical and regulatory terminology.
Strong project management and problem-solving skills.
Proficiency in data analysis and interpretation of clinical trial data.
Effective cross-functional collaboration and communication abilities.
Leadership skills for guiding global teams and managing risks.
Integrity, attention to detail, resilience, and a commitment to innovation and continuous improvement.
PhD in biological sciences preferred; experience in clinical pathology or clinical development within the IVD industry.

What We Offer: We offer an exciting opportunity to join a dynamic team where you will drive impactful clinical studies while ensuring compliance with regulatory standards. Our collaborative and innovative work environment provides opportunities for professional growth and the chance to contribute to significant advancements in healthcare.

We look forward to welcoming you to our team!

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