Clinical Affairs Manager

About the position #

As a Clinical Affairs Manager, you will be responsible for driving clinical activities that support product registration and market access. This includes managing clinical evaluations, post-market surveillance, and related documentation across the product lifecycle. You will collaborate with cross-functional teams and act as a key point of contact for clinical matters, ensuring compliance with regulatory requirements and supporting the strategic goals of ndd’s product portfolio. Do you want to help us to make lung function testing accessible to everyone everywhere, and to improve the lives of millions of people with lung diseases? Then you have come to the right place!

Why us? #

We offer an attractive location, fair pay, good social benefits, flexible working hours, hybrid work, and the best conditions in which to do excellent work. This includes comprehensive onboarding, professional and modern technology, and a collegial and supportive working environment. We promote equal opportunities, diversity, and inclusion – come as you are!
If this profile describes you and you would like to work at a fast-growing company in a global environment, then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you, the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.

Tasks #

• Lead and manage Clinical Affairs activities, including defining clinical strategies and overseeing related projects across the product lifecycle.
• Develop and maintain key clinical documentation, including Clinical Evaluation Plans and Reports, and SOTA assessments.
• Plan and manage Post-Market Surveillance activities, including PMCF activities.
• Act as a subject matter expert, ensuring effective collaboration with internal teams and external stakeholders.
• Ensure compliance with clinical claims and marketing materials and support audits and regulatory feedback responses.
• Manage service providers and contribute to training initiatives within Clinical Affairs.
• Continuously improve and maintain Clinical Affairs and Post-Market Surveillance processes.

Your profile #

• Bachelor’s or master’s degree in relevant science (e.g. LifeSciences, Biomedical Engineering) or equivalent.
• 7+ years of experience in clinical and / or regulatory affairs in the medical device industry.
• Strong knowledge of clinical development and evaluation of medical devices.
• Proficient in MS Office and other relevant computer systems (e.g. Polarion, Teamcenter, Salesforce).
• Hands-on personality with strong organization skills and ability to take full responsibility of the assigned areas.
• Strong project management skills, with the ability to handle multiple projects and meet deadlines.
• Proven experience handling the definition and implementation of remedial actions in response to feedback from notified bodies or health authorities.
• Strong background in technical and/or scientific writing, with hands-on experience in preparing and managing technical documentation.
• Fluent in English and German; additional languages are a plus.

We are looking for passionate people who can easily identify with our company, who bring drive, expertise, and good vibes to our enterprise. People who appreciate the community and know that sharing talents and information to achieve common goals and objectives is the best way to develop.