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.