Lead the development of clinical evaluation strategies for medical devices within the Craniomaxillofacial (CMF) business unit, ensuring alignment with global regulatory requirements and market access goals. This position plays a central role in generating and validating clinical evidence to support device safety, performance, and benefit-risk assessments.
Key Responsibilities
- Develop and maintain clinical evaluation plans, reports, and post-market surveillance documentation across the product lifecycle.
- Design and execute systematic literature reviews using compliant search methodologies to gather relevant scientific data.
- Interpret clinical evidence and emerging medical trends to support regulatory submissions and product claims.
- Collaborate with regulatory, R&D, marketing, and clinical research teams to define intended use, indications, and risk profiles for new and existing devices.
- Translate complex clinical findings into clear, accurate messaging for internal and external audiences.
- Review promotional materials to ensure scientific accuracy and regulatory compliance of performance and safety statements.
- Engage with regulatory authorities to clarify evidence expectations and support submission success.
- Identify data gaps and contribute to planning preclinical and clinical studies to strengthen product dossiers.
- Lead cross-functional review cycles, resolve feedback, and ensure timely document approvals.
- Advocate for process improvements and best practices in clinical documentation and evidence generation.
- Mentor team members and act as a subject matter expert on clinical evaluation standards.
Qualifications
Applicants must hold a Master of Science in a health or science-related discipline, with at least four years of experience in clinical, regulatory, or quality affairs. A minimum of three years dedicated to writing clinical evaluations for medical devices is required. Proven ability to interpret regulatory standards, manage complex projects independently, and communicate scientific concepts clearly is essential.
Strong analytical, writing, and organizational skills are expected, along with the ability to make sound judgments under limited guidance. Experience working across multidisciplinary teams and with external partners such as clinicians and research organizations is highly valued. A doctorate in a relevant field is preferred but not mandatory.
Work Environment
This hybrid role is based in Freiburg, Germany, with flexibility for remote and on-site work. The ideal candidate thrives in a self-directed environment, builds strong collaborative relationships, and turns data into actionable insights for decision-makers across the organization.
