Clinical Affairs & MDR Consultant – Medical Devices

Responsibilities

Qualification:

Framework data:

• Creation, revision, and review of clinical evaluation documentation, especially Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and State of the Art Reports.
• Creation and updating of Post-Market Clinical Follow-up (PMCF) plans and reports, including the evaluation of clinical data and resulting actions.
• Review and updating of dependent regulatory documentation, especially Instructions for Use (IFU), Summary of Safety and Clinical Performance (SSCP), and clinically relevant risk assessments.
• Support in the preparation and execution of annual updates of clinical documentation for the supported medical devices.
• Technical coordination with the internal MDR Clinical & Regulatory Team as well as external service providers and support in meetings with the Notified Body (TÜV SÜD).
• Analysis and processing of regulatory inquiries, especially Lists of Questions and Deficiencies from the Notified Body within the scope of MDR-compliant CE certification.
• Derivation and implementation of necessary adjustments to clinical documentation based on regulatory feedback.
• Creation of presentation materials for the presentation of clinical evaluations, project progress, and decision-making bases for any necessary additional clinical studies.
• Support in the conception and development of study outlines for possible PMCF studies as well as in the definition of necessary clinical data generation measures
• At least 5 years of relevant professional experience in Clinical Affairs, Clinical Evaluation, or Clinical Regulatory Affairs for medical devices.
• Sound knowledge of European medical device regulations, especially MDR (EU 2017/745), MDD, and MEDDEV, including the classification of medical devices.
• Demonstrable practical experience in the creation, revision, and updating of clinical documentation, especially CEP, CER, PMCF Plan/Report, and SSCP.
• Experience with Class III medical devices, ideally in the field of dermal fillers or comparable aesthetic medical products.
• Sound knowledge in the field of clinical studies for medical devices as well as experience in the creation of Study Outlines and Clinical Investigation Plans.
• Experience in collaboration with Notified Bodies, manufacturers, and external regulatory service providers.
• Knowledge in the evaluation of clinical data as well as in the derivation of regulatory and clinical measures.
• Experience with clinical studies in the pharmaceutical (Drugs) sector is desirable.
• Strong medical writing competence as well as fluent English skills, both written and spoken.

Project details

1.1.2027

12 months

Utilization: 20h/week

Remote and Germany

• Start: ASAP
• Duration: 12 months
• Remote: hybrid
• Location: Germany, DE
• Languages: English, German