Job Details

Digital Health Platform and Compliance Lead (SaMD) (w/m/d)

Solothurnerstrasse 235, Switzerland | Olten | Full-time

Job Description

  • Develop and maintain a deep understanding of regulatory requirements related to Digital Health Platform, SaMD and Connected Medical Devices, including but not limited to FDA QSR, MDR, GxP, ISO 13485, and IEC 62304.
  • As the lead for the outsourcing strategy of “legal manufacturer service”, you will be responsible for identifying, evaluating and selecting potential service providers for placing our digital health products in US and EU markets. You will also manage the commercial agreements and be in the point of contact for all related topics (e.g. supplier quality).
  • Work closely with the Digital Health Engineering team to be the proxy for knowledge on processes and ways for working with third party QMS.
  • Work closely with the QA and RA team to align on the needs of any “bridging” processes required as part of the legal manufacture service usage.
  • Develop and execute a roadmap for the digital health platform, including feature development and release cycles.
  • Manage cross-functional teams including software, DPO, infrastructure, architect teams and suppliers to define the platform, obtain agreement in implementation strategies and create greenfield architectures (when required).
  • Collaborate with Digital Solutions and Disease Leads to understand the use-case needs and ensure that the digital health platform caters for this needs through development and integration with systems and various systems and devices.
  • Ensure that the digital health platform is compliant with applicable regulations, including HIPAA, GDPR, CCPA etc.


  • Minimum 5 years of professional experience in managing the development and implementation of regulated products in QMS in a medical devices environment
  • Strong understanding of regulatory requirements related to medical device products, including FDA QSR, MDR, ISO 13485, IEC 62304, HIPAA, GDPR and CCPA.
  • Experience with Agile development methodologies.
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
  • Strong problem-solving and analytical skills.
  • Ability to prioritize and manage multiple projects simultaneously.
  • Experience with cloud-based technologies.
  • Strong entrepreneurial spirit to perform in our startup-like environment, and the willingness to take responsibility beyond your main tasks.
  • You are motivated by an intense and varied work environment. You are eager to learn, adaptive and hands-on.
  • Excellent written and oral communication skills in English. German is a plus.

Additional Information

We offer a challenging, international environment and the opportunity to actively contribute to the company and different teams with knowledge and engagement, and to develop personally. We also offer a modern workplace in a historic building, advanced and flexible working conditions as well as salaries according to performance and well-developed social benefits.

Interested? Please upload your complete application (letter of motivation, CV, job references, diplomas / certificates) by clicking on the "apply now" button. We look forward to reading from you.

Your contact person - For further information please contact us, +41 62 209 71 00

About Gerresheimer

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Equal rights

All applicants are considered without any regard to race, color, creed, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status.

Interested? Apply today!