We are looking forward to having you in our team as experienced and constructive Regulatory Affairs Specialist!
Regulatory Affairs Specialist Medical Devices
You want to change people’s lives? Well, we at Hocoma do this every single day - with game-changing and innovative technologies that improve human movement therapy for millions of patients around the world. With over 20 years pioneering the advancement of rehabilitation technology, Hocoma products and technologies can be found in the most forward-thinking neuro-rehab facilities, top hospitals and stand-out clinics, changing lives for the better daily. Hocoma, along with other market leaders such as Motek and Fysioroadmap, is part of the DIH group advancing medical technologies around the world.
Join us and become a part of a global network of leading brands to redefine the therapy standards of tomorrow – today!
ARE YOU INSPIRED BY…
- Performing and supporting medical device and company registrations internationally in a timely manner?
- Providing reliable regulatory guidance in development projects?
- Creating and maintaining product-specific STED documentation?
- Ensuring compliance with all regulatory requirements for assigned projects?
- Ensuring up-to-date knowledge in quality and product relevant standards, laws and guidelines?
- Supporting the quality team in product and process audits?
- Leading assigned vigilance tasks, such as Adverse events, Field Safety Corrective Actions, etc.?
- Supporting the Head of QM & RA and/or other positions in quality-related matters?
WE MATCH WITH PEOPLE WHO...
- Enjoy working in multicultural teams and discussing and solving challenges in a global matrix organization.
- Are self-driven, goal-oriented and forward-thinking personalities.
- Have good judgement and have a proactive approach to work.
- Keep a clear head, and work out pragmatic solutions.
- Are flexible and keep their eye on the ball in a dynamic environment.
- Communicate transparently, clearly and persuasively.
- A Bachelor's degree in engineering, science, quality or regulatory.
- 5+ years of relevant work experience in a GMP environment, ideally in an international medical device company.
- Previous proven experience in industry with requirements such as ISO 13485, CFR 820, GMP, MDD, MDR, MDSAP.
- Excellent interpersonal and communication skills, and the ability to perform in a complex, global environment.
- Excellent problem solving and negotiation skills.
- Very good German and English language skills, other languages are an asset.
Leading. Innovative. Reliable. Human. Integrity. Passionate.
That is what we stand for. What do you stand for?
Please include your compelling motivation letter that points out why you match with us, and your resume when applying on our website.
If you have any questions, please reach out to: Ms. Eliane Lehner (HR Business Partner) +41 43 444 22 00. Remote work / home office based possible.