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Tasks & Responsibilities
Support the clinical strategy and clinical evidence generation for medical device products across their lifecycle.
Plan, coordinate and/or oversee clinical activities, such as clinical investigations and other clinical evidence activities, including timelines, vendors/sites, documentation and quality.
Prepare, review and maintain clinical and regulatory-facing documentation (e.g., clinical plans/reports, study documentation, literature reviews, clinical summaries).
Conduct or support systematic literature searches and evaluation of clinical evidence, including state-of-the–. benefit–risk considerations.
Contribute to post-market clinical activities and surveillance‑related deliverables (e.g., PMCF activities and reporting, inputs to PMS/PSUR where applicable).
Support submissions and communications with relevant stakeholders (e.g., Ethics Committees, competent authorities, Notified Bodies), in collaboration with Regulatory Affairs and other functions.
Collaborate cross‑functionally (Regulatory, Quality, R&D, Medical/Marketing, Project Management) to ensure alignment of clinical requirements and product documentation.
Track progress of clinical activities, ensure appropriate documentation and data quality, and support the use of systems/tools (e.g., EDC, document management).
Ensure compliance with applicable internal procedures and external requirements/standards (e.g., MDR, ISO 14155, GCP and related guidelines as relevant).
Profile & Qualifications
Degree in a life sciences, medical, engineering or comparable field (Bachelor/Master/PhD depending on seniority).
Experience in Clinical Affairs/Clinical Research/Medical Affairs within medical devices (or closely related regulated industry); suitable for both developing and experienced profiles.
Familiarity with clinical documentation and clinical evidence evaluation; experience with clinical investigations and/or post‑market activities is a plus.
Basic understanding of relevant regulations and standards (EU MDR/IVDR as applicable; ISO 14155/GCP; MEDDEV/MDR clinical evaluation concepts). Broader global exposure (e.g., FDA) is an advantage.
Comfortable working with clinical data and documentation; basic biostatistics knowledge is beneficial.
Strong English skills; German skills are an advantage (or depending on role/location).
Structured, quality‑focused and solution‑oriented working style; able to manage multiple priorities.
Collaborative mindset and strong communication skills in interdisciplinary, international teams.
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