Senior Clinical Affairs Manager, Port

Responsibilities

Development and implementation of the clinical strategy for the entire product portfolio

Creation, review and maintenance of Clinical Evaluation Reports (CER) in accordance with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV

Conduct of systematic literature searches and critical appraisal of clinical evidence and state-of-the-art analyses

Independent planning and execution of Post-Market Clinical Follow-up (PMCF) activities including PMCF Plan and PMCF Evaluation Report

Authoring and review of clinical study protocols according to ISO 14155 and GCP

Close collaboration with Regulatory Affairs in the creation and maintenance of technical documentation (Technical Files)

Clinical input for PMS processes, PSURs, and support of regulatory submissions and communication with Notified Bodies

Professional guidance and mentoring of junior team members and active knowledge sharing within the team

Independent representation of clinical positions towards management, Notified Bodies and regulatory authorities

Qualifications

Degree in medical engineering, natural sciences or a comparable field (Master's or higher preferred)

Minimum 5 years of relevant experience in Clinical Affairs within the medical device industry

Proven expertise in independently authoring Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)

Sound knowledge of PMCF planning and execution in accordance with the MDR

Experience in authoring clinical study protocols according to ISO 14155 and GCP

Familiarity with Technical Files / technical documentation under the MDR; knowledge of additional regulatory markets (FDA, Health Canada, etc.) is an advantage

Strong knowledge of EU MDR 2017/745 and relevant standards (ISO 14155, ISO 14971, MEDDEV guidelines)

Experience working with Notified Bodies as well as audits and technical reviews

Confident, assertive personality with a proactive approach and a high sense of personal responsibility

Ability to share knowledge and act as a subject matter expert within the team

Strong team player with high social competence; open personality who enjoys interdisciplinary collaboration

High quality awareness, analytical strength and a pronounced scientific mindset

Strong organizational skills and ability to prioritize in a dynamic environment

Solution-oriented thinking, precise and structured way of working

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