Digital Health Platform and Compliance Lead
vor 6 Stunden
Company Description
We are on an exciting journey as we take an active role in creating the future of the digital healthcare ecosystem. You will decisively contribute to the way chronic diseases are managed by taking advantage of the latest technological advances. If you are fascinated with developing medical software and you bring a fresh mind with new ideas on how to bring better quality of life to patients, we are happy to offer you a place where you get the independence to creatively contribute to the future of healthcare.
As a listed MDAX company, Gerresheimer is a leading global partner to the healthcare and cosmetics industries. We generate sales of around 1.6 billion euros and are represented worldwide with about 10,000 employees. You will join a young and diverse digital innovation team and take the lead in turning ideas and concepts into market-ready digital health solutions.
**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.
**Qualifications**:
- 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.
**Your contact person - **For further information please contact us, +41 62 209 71 00
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