Senior Scientific Manager - Medizintechnik (m/w/d)

Coloplast; Deutschland; Hybrid; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Remote work up to 2 days per week

30 days annual vacation

Company events

Company benefits program

Zusammenfassung

Coloplast Nieder-Olm is seeking a Senior Scientific Manager to drive clinical documentation for medical devices. You will join the Scientific Management team, ensuring high-quality, regulatory-compliant documents to support development, approval, and commercialization.

The role requires a medical or life sciences degree, 3+ years in Medical Affairs/Scientific Management, CER/PMCF experience, MDR/MEDDEV knowledge, strong writing, and fluent German and English.

Qualifikationen

• Degree in Medicine, natural or life sciences or equivalent.
• Several years in Medical Affairs, Clinical or Scientific Management.
• Experience with CERs and PMCF documentation.
• Knowledge of MDR/MEDDEV and ISO 13485.
• Ability to translate scientific data into clear regulatory documents.
• Excellent scientific writing and communication skills.
• German and English proficiency at C1 level.

Aufgaben

• Prepare and maintain high-quality clinical documentation per regulatory standards.
• Create CERs and PMCF reports per MDR/MEDDEV requirements.
• Provide scientific guidance to Development, Product Management, Regulatory Affairs.
• Collaborate with internal stakeholders on product development and regulatory submissions.
• Conduct literature searches and analyze clinical data.
• Review marketing and training materials for scientific accuracy.
• Assist audits, inspections, and regulator inquiries.
• Contribute to clinical strategies and cross-functional decisions.
• Support product trainings, launches, and international MedTech seminars.
• Improve processes and standards within Scientific Management.

Kenntnisse

German fluency

English fluency

Regulatory knowledge

Clinical writing

Cross-functional collaboration

Ausbildung

Medical or life sciences degree

Tools

Veeva

JMP

Microsoft Office

Jobbeschreibung

Location: Nieder-Olm, DE

Job Family: Marketing

EN - Job Advertisement

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

Senior Scientific Manager - Medical Devices (m/f/d)

Stellenumfang: Vollzeit, 40 Wochenstunden / 1 FTE

Beschäftigungsart: Festanstellung, unbefristet / Vakant ab sofort

Standort: TRACOE medical GmbH, Nieder-Olm / Deutschland

Bewerbungsfrist: 30.09.2026

Role Purpose

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.

Key Responsibilities

• 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 MedTech seminars.
• Continuously improve processes, methodologies, and standards within Scientific Management.

Qualifications & Professional Experience

• 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.

Travel Requirements

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

What We Offer

• The opportunity to actively contribute your scientific expertise to product development and clinical strategy.
• A responsible position within an international environment.
• A structured onboarding process and a collaborative team culture.
• Flat hierarchies and short decision-making processes.
• Creative freedom and the opportunity to make a meaningful impact.
• Flexible working hours and the option to work remotely (up to 2 days per week).
• Individual training and professional development opportunities.
• 30 days of annual vacation, plus an additional 0.5 days each on December 24 and December 31, and on Rose Monday.
• Attractive additional benefits including Corporate Benefits, bicycle and e-bike leasing through CompanyBike, employee referral bonuses, special gifts for birthdays and work anniversaries, and much more.
• Company events and free employee parking.

Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox, Provox Life and Tracoe.

We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business.

Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.

Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S