Tasks/Responsibilities:

• Define the regulatory requirements for clinical studies (e.g. for CE-registrations and PMCF studies), support the clinical team to establish study protocols in collaboration with health care professionals and support project management of clinical investigation projects
• Provide and update Clinical Evaluations (Plan and Report), Post-Market-related regulatory documentation, such as: Post-market Clinical Follow-up (plan and report), Post-market Clinical Studies, Periodic Safety Update Report as well as coordination of related processes
• Setting up, managing and coordinating multiple global clinical trials
• Evaluation of regulatory relevant clinical data
• Conduct scientific literature searches, evaluations and reviews according to MDR as required e.g. in the Clinical Evaluation
• Collect and process feedback form the market, support vigilance and Field Safety Corrective Actions, monitoring clinical safety of our products, update the product related risk assessments and plan actions to mitigate risks, benefit-risk evaluation report
• Coordinate cross-functional teams and collaborate with Quality Management, Regulatory Affairs, Design & Development, Manufacturing, R&D as well as external service providers to support clinical evaluation documentation, PMCF and PMS
• Support market access of new products
• Perform qualification assessments of study centers
• Conduct annual market analysis for competitive products to identify equivalence to existing devices
• Act as a subject matter expert in audits

The must-have / minimum requirements are in bold

Qualification:

• Degree in medicine, medical technology, or life science/natural sciences with a medical background or an equivalent qualification
• Long-time / in-depth industry experience in Medical or Clinical Affairs
• Professional experience in the medical device environment (class III) with a focus on aesthetics / plastic surgery (ideally breast implants)
• Professional experience in the planning and conducting of global clinical trials
• Proven track record in creation, editing and proof-reading of clinical documents to assess the safety and performance, in accordance with applicable standards
• Knowledge in regulatory requirements (MDR, relevant MDCGs; ISO 13485, ISO 14971, ISO 14155)
• Knowledge in regulatory requirements in the US (FDA)
• Skilled in managing cross-functional projects
• Proficient in English language (spoken and written) & excellent communicator with strong collaboration abilities, German would be beneficial
• Very good IT-Skills & willingness to travel

Art der Stelle: Vollzeit
Gehalt: 65.000,00€ - 75.000,00€ pro Jahr

Arbeitszeiten:

• Montag bis Freitag

Leistungen:

• Betriebliche Altersvorsorge
• Betriebliche Weiterbildung
• Firmenevents
• Firmenhandy
• Flexible Arbeitszeiten
• Gleitzeit
• Homeoffice-Möglichkeit
• Kostenlose Getränke
• Sprachkenntnisse werden vermittelt

Berufserfahrung:

• Clinical/Medical: 5 Jahre (Erforderlich)

Sprache:

• Englisch und/oder Deutsch (Erforderlich)

Arbeitsort: Zum Teil im Homeoffice in 04103 Leipzig
Bewerbungsfrist: 28.02.202

• Define the regulatory requirements for clinical studies (e.g. for CE-registrations and PMCF studies), support the clinical team to establish study protocols in collaboration with health care professionals and support project management of clinical investigation projects
• Provide and update Clinical Evaluations (Plan and Report), Post-Market-related regulatory documentation, such as: Post-market Clinical Follow-up (plan and report), Post-market Clinical Studies, Periodic Safety Update Report as well as coordination of related processes
• Setting up, managing and coordinating multiple global clinical trials
• Evaluation of regulatory relevant clinical data
• Conduct scientific literature searches, evaluations and reviews according to MDR as required e.g. in the Clinical Evaluation
• Collect and process feedback form the market, support vigilance and Field Safety Corrective Actions, monitoring clinical safety of our products, update the product related risk assessments and plan actions to mitigate risks, benefit-risk evaluation report
• Coordinate cross-functional teams and collaborate with Quality Management, Regulatory Affairs, Design & Development, Manufacturing, R&D as well as external service providers to support clinical evaluation documentation, PMCF and PMS
• Support market access of new products
• Perform qualification assessments of study centers
• Conduct annual market analysis for competitive products to identify equivalence to existing devices
• Act as a subject matter expert in audit