You will be responsible for leading the Product Compliance Team for the Medical and Applied Business Units. Furthermore, you will check the product compliance of devices and systems as well as their documentation within the framework of the Leica strategy. Due to project specifications, European and international regulations for market access and product safety you will ensure that our products comply with the standards and the necessary documentation.
Teamlead Product Compliance and Documentation (m/f/d), Heerbrugg (Switzerland)
- Close cooperation with Marketing, R&D, Industrial Engineering and Regulatory Affairs & Quality Insurance.
- Documentation, testing and approval of systems to ensure product compliance, market access requirements and product safety.
- Contact person for external testing institutes (TÜV, UL, etc.) regarding our product range. Coordination of tests at external testing institutes, elaboration and implementation of necessary modifications to achieve normative requirements.
- Creation, monitoring and maintenance of test reports, technical documentation, document templates, concepts and versions for the compliance file (test reports, checklists, manuals, overview lists, etc.).
- University degree in technical sciences or engineering with a focus on electronics and mechanics.
- Several years of professional experience in a comparable position e.g. in Product Compliance or Technical Documentation.
- Proven experience in the product segment of technologically sophisticated products ideally in the field of microscopy or robotics.
- Ideally knowledge of product relevant laws and standards: European Low Voltage Directive, Electro Magnetic Compatibility, Medical Devices Directive and regulatory requirements in: MDD (93/42/EEC) and Risk Management (ISO 14971).
- Experience in management of people.
- Experienced to work in interdisciplinary teams.
- Language skills: fluent German and English.
What we have to offer:
- With us, you can expect varied, challenging tasks that you can master with great colleagues at your side.
- Flexible working hours and partly home office.
- As part of the Danaher Group, you will have access to exciting internal programs for promotion and further development.
Are you interested in working in a dynamic and team-oriented environment and are you ready to break new innovative ground with us? Then apply online with your complete documents (cover letter, resume, references) and your salary expectations.
We look forward to receiving your application!