Risk Manager

vor 4 Wochen

Salzburg, Österreich Technolution Vollzeit

**Ready to bloom and unleash your expertise in a thriving space?**

**As **Risk Manager **at Technolution** you will lient projects and assist in identifying, assessing, and managing risks associated with medical devices, especially combination devices.

**With direct report** to Senior Partner and Head of Design Control you will be part of a team of ten people. You will often collaborate with your colleagues from Usability Engineering, QA, Design Control, Labeling Specialists and Mechanical Engineering on the various projects.

**Your main responsibilities are**:

- Risk Management Plan
- Risk Assessment
- Benefit-risk Report
- Compliance with Regulatory Requirements
- Documentation and Reporting

**Your qualifications are **extensive hands-on experience with the ISO 14971 standard, ISO 13485, 21 CFR Part 820 and contributing with input to submissions for CE-Marking, and FDA 510(k). In this role, it is essential to have a deep understanding of medical devices, particularly combination products and the ability to identify and assess potential risks. In addition, familiarity with regulatory requirements and working collaboratively with various stakeholders are vital to ensuring patient safety and product quality.

**You have a Master’s Degree** in Engineering; Pharmacology; Molecular Biology or similar.

**You are a person **who takes a holistic view of the development process, and you thrive working with highly qualified teams on diverse projects with start-ups to industry leaders. You find it natural to build good relations with clients and colleagues.

**Technolution offers** an unparalleled opportunity for you to flourish and enhance your skill set within an invigorating atmosphere.

**Place of work**: Mainly at the client’s site and each Friday at the office.

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