Regulatory Affairs Expert

vor 1 Tag

Solothurn, Schweiz Helvetica Partners Vollzeit

We are currently looking on behalf of one of our important clients for a Regulatory Affairs Expert. The role is a permanent position based in Solothurn Canton.

Your Role:

- Carry out tasks to support a rapidly developing digital offering.
- Support & prepare product submission documents, with main focus on USA, Canada, China, & the EU.
- Prepare regulatory strategies.
- Support development projects with a focus on regulatory aspects.
- Evaluate change requests.
- Review quality agreements with customers on regulatory aspects.
- Communicate & correspondence with authorities.
- Cooperate in QMS ISO 13485 & 21 CFR 820 audits.
- Partake in general QM tasks (Creation of Q-documents, trainings etc.).

Your Skills:

- At least 3 years of professional experience in Regulatory Affairs, including experience with a focus on Medical Devices.
- Ideally experienced in the areas of Active Medical Devices, Software as a Medical Device, Digital Health & US & China registrations.

Your Profile:

- Completed University Degree in Natural / Medical Sciences / Engineering or equivalent training.
- Highly organized & efficient.
- Skilled in communicating effectively with different stakeholders & on different levels.
- Fluent in English (spoken & written) & a good command of German (At least B1 Level).

If you wish to apply, please send us your resume in Word or PDF format.

You can also register on our website which will allow you to receive other exclusive and confidential job offers.

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