Senior Clinical Affairs Manager
We are a leading innovator in the medical device industry, specializing in cutting-edge Class III devices designed to improve patient outcomes and set new benchmarks in healthcare technology. Our team is driven by a commitment to excellence, innovation, and patient safety, and we are seeking a highly motivated Senior Clinical Affairs Manager to join our growing organisation in Freiburg, Germany.
Position Overview :
As the Senior Clinical Affairs Manager, you will play a pivotal role in driving the clinical strategy and execution of clinical programs for our innovative Class III medical devices. You will lead cross-functional teams, manage clinical trials, and ensure compliance with global regulatory requirements while contributing to the development of groundbreaking technologies that improve patient care.
Key Responsibilities :
Clinical Strategy Development :
- Design and implement clinical strategies to support product development, regulatory submissions, and post-market activities.
- Collaborate with R&D, regulatory, and marketing teams to align clinical goals with business objectives.
Clinical Trial Management :
Oversee the planning, execution, and management of clinical trials, including protocol development, site selection, and monitoring.Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory requirements.Manage relationships with clinical investigators, Contract Research Organizations (CROs), and other external partners.Regulatory Support :
Develop and deliver clinical evidence to support CE marking, FDA submissions (e.g., IDE, PMA), and other global regulatory approvals.Represent the clinical affairs function during regulatory authority interactions and audits.Data Analysis and Reporting :
Interpret clinical data, prepare study reports, and present findings to internal and external stakeholders.Contribute to publications, white papers, and conference presentations.Leadership and Collaboration :
Mentor and manage junior team members within the Clinical Affairs department.Foster cross-functional collaboration to ensure clinical objectives are met efficiently and effectively.Qualifications : Education :
Bachelor's degree or higher in Life Sciences, Medicine, Biomedical Engineering, or a related field.Experience :
Minimum of 5 years of experience in clinical affairs within the medical device industry, with a focus on Class III devices.Proven track record in managing clinical trials, from planning to completion.Comprehensive knowledge of EU MDR, FDA regulations, and other relevant standards (ISO 14155).Skills :
Strong leadership, organizational, and project management skills.Excellent communication and interpersonal abilities, with fluency in English (German proficiency is a plus).Analytical mindset with the ability to interpret and present complex clinical data.What We Offer :
Competitive compensation and benefits package.Opportunity to work on groundbreaking technologies in a collaborative and innovative environment.Career development opportunities in a global organization.A vibrant, high-quality work-life environment in the heart of Freiburg, Germany.