Senior Clinical Affairs Manager 100%

Senior Clinical Affairs Manager 100%

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

Profile:

• 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
• Solution-oriented thinking, precise and structured way of working

Ton interlocuteur/trice :

Ton contact pour ce poste est Leila. Avec plus de 15 ans d'expérience dans le domaine du recrutement, il/elle saura t'accompagner, te conseiller et t'apporter la réponse à toutes tes questions concernant le poste. Nous ne répondrons qu'aux candidatures dont le profil correspond au descriptif demandé.