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- Aufgaben: Lead clinical studies and ensure compliance with regulatory standards across EMEA.
- Arbeitgeber: Join a dynamic team focused on impactful advancements in healthcare.
- Mitarbeitervorteile: Enjoy remote work options and opportunities for professional growth.
- Warum dieser Job: Make a difference in healthcare while collaborating with global teams in an innovative environment.
- Gewünschte Qualifikationen: PhD in biological sciences preferred; experience in clinical development or IVD industry required.
- Andere Informationen: Stay updated on EU regulatory requirements and contribute to significant healthcare advancements.
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
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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Clinical Development and Affairs Manager EMEA Arbeitgeber: Hologic, Inc.
Kontaktperson:
Hologic, Inc. HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Clinical Development and Affairs Manager EMEA
✨Tip Number 1
Familiarize yourself with the CE-IVDR requirements and UKCA regulations. Understanding these regulatory frameworks will not only help you in interviews but also demonstrate your commitment to compliance and quality in clinical development.
✨Tip Number 2
Network with professionals in the clinical development field, especially those who have experience with in-vitro diagnostic technologies. Engaging with industry experts can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Stay updated on the latest trends and advancements in clinical trials and regulatory affairs. Being knowledgeable about current events in the industry will allow you to speak confidently about relevant topics during discussions with our team.
✨Tip Number 4
Prepare to discuss your project management experiences and how you've successfully collaborated across functions in previous roles. Highlighting your leadership skills and problem-solving abilities will be crucial in showcasing your fit for this role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Clinical Development and Affairs Manager EMEA
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements. Highlight your relevant experience in clinical development processes, regulatory knowledge, and project management skills.
Tailor Your CV: Customize your CV to reflect the specific skills and experiences that align with the role of Clinical Development and Affairs Manager. Emphasize your familiarity with CE-IVDR and UKCA regulations, as well as your expertise in in-vitro diagnostic technologies.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical development and your understanding of the regulatory landscape. Mention specific examples of how you have successfully managed studies or collaborated with cross-functional teams in the past.
Highlight Leadership and Collaboration Skills: In your application, emphasize your leadership abilities and experience in guiding global teams. Provide examples of effective communication and collaboration with various departments, such as R&D and Regulatory Affairs, to demonstrate your fit for the role.
Wie du dich auf ein Vorstellungsgespräch bei Hologic, Inc. vorbereitest
✨Understand Regulatory Requirements
Make sure you have a solid grasp of CE-IVDR and UKCA regulations. Be prepared to discuss how your knowledge can help the company maintain compliance and support evidence generation studies.
✨Showcase Your Project Management Skills
Highlight your experience in managing clinical studies and protocols. Provide examples of how you've successfully led projects, navigated challenges, and ensured timely completion.
✨Demonstrate Cross-Functional Collaboration
Prepare to discuss instances where you've worked closely with R&D, Regulatory Affairs, and Clinical Affairs. Emphasize your communication skills and ability to bridge regional requirements with global functions.
✨Stay Updated on Industry Standards
Familiarize yourself with the latest clinical trial guidelines and ethical standards. Being knowledgeable about ongoing trials in the region will show your commitment to staying informed and relevant in the field.
