Senior Scientific Manager - Medizintechnik; m​/w​/d

Location:

Nieder-Olm, DE

Job Family:
Marketing

We are a medium-sized, rapidly growing company in the medical device industry based in Nieder-Olm near Mainz, Germany. As part of the Atos Medical / Coloplast Group, we develop and market innovative Voice & Respiratory Care solutions, sustainably improving the quality of life of our patients worldwide. Flat hierarchies, short decision-making processes, a strong spirit of innovation, and an open corporate culture define who we are.

We are currently seeking a

Stellenumfang: Vollzeit, 40 Wochenstunden / 1 FTE

Beschäftigungsart: Festanstellung, unbefristet / Vakant ab sofort

Standort: TRACOE medical GmbH, Nieder-Olm / Deutschland

Bewerbungsfrist: 30.09.2026

The Scientific Management team is responsible for the creation of clinical documentation that meets scientific, regulatory, normative, economic, and quality requirements. As a strategic partner and advisor, the team supports various functional areas in scientific and clinical-regulatory matters. The purpose of this role is to ensure the development and maintenance of scientifically sound, compliant, and high-quality clinical documentation to support the development, approval, and commercialization of our medical devices.

• Preparation and maintenance of high-quality clinical documentation in accordance with applicable regulatory requirements and scientific standards.
• Preparation of Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up Reports (PMCFs) in accordance with MDR and MEDDEV requirements.
• Provide scientific guidance and support to the Development, Product Management, PLM, Regulatory Affairs, and Vigilance departments on scientific and clinical matters.
• Close collaboration with internal stakeholders to support product development activities, product changes, and regulatory submissions.
• Conduct literature and database searches as well as analyze and evaluate clinical data.
• Review and approval of marketing and training materials for scientific accuracy and regulatory compliance.
• Support audits, inspections, and regulatory authority inquiries.
• Contribute to clinical strategies, scientific assessments, and cross-functional decision-making processes.
• Conduct and support product trainings, product launches, and international Med Tech seminars.
• Continuously improve processes, methodologies, and standards within Scientific Management.

• Completed degree in Medicine, Natural Sciences, Life Sciences, or a comparable qualification.
• Several years of professional experience (minimum 3 years) in Medical Affairs, Medical Science, Clinical Affairs, or Scientific Management.
• Experience in the preparation of clinical documentation, particularly Clinical Evaluation Reports (CERs) and PMCF documentation.
• Strong knowledge of regulatory requirements for medical devices, particularly MDR, MEDDEV, and ideally ISO 13485.
• Experience in evaluating scientific literature and analyzing clinical data.
• Excellent scientific writing skills and the ability to communicate complex topics in a clear and understandable manner.
• Knowledge of tracheotomy, tracheostomy tube management, ventilation, or related medical fields is considered an advantage.
• Proficient in Microsoft Office (Word, Excel, PowerPoint); experience with Veeva, JMP, or comparable systems is desirable.
• Fluent German and English language skills, both written and spoken (minimum C1 level).
• Strong ability to collaborate across functions and professionally interact with internal and external stakeholders.

• Approximately once per quarter, with travel durations of up to one consecutive week.

• The…