Director Regulatory Affairs
vor 5 Stunden
Who we are
You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.
We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.
If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.
Join Sonova. Create sense.
- Staefa, SwitzerlandDirector Regulatory Affairs
- As a Director Regulatory Affairs you will play a pivotal role in providing regulatory support and guidance to our project teams and regulatory staff. This position involves preparing submissions for regulators globally, devising regulatory strategies for timely approval of devices, and being the main point of contact for competent authorities and certification labs. You will also be responsible for developing and overseeing post-market follow-up activities and leading a team.**Your tasks**
- Ensuring the conformity of devices before release to the market and maintaining updated technical documentation and declarations of conformity
- Providing comprehensive product compliance and technical documentation for all relevant geographies
- Fulfilling reporting obligations
- Monitoring worldwide standards related to medical and radio equipment and keeping track of changes in regulatory requirements
- Serving as the contact person for competent authorities, Notified Bodies, and certification laboratories
- Supporting stakeholders in the certification, registration, or type approval process for medical devices
- Acting as the Person Responsible for Regulatory Compliance (PRRC) as per EU MDR 2017/745
- Owning the Regulatory Affairs Management Process and implementing, maintaining, and improving SOPs for product compliance
**Your profile**
- Bachelor's or Master's Degree or equivalent in a related field (Life Sciences)
- Knowledge of ISO 13485, 93/42/EEC MDD, EU 2017/745 MDR, QSR 21CFR820, MDSAP
- Minimum of 8 years of experience in regulatory affairs for medical devices, preferably in a large manufacturing or healthcare company
- Excellent problem-solving, organizational, analytical, and critical thinking skills
- Strong influencing and presentation skills, excellent command of English, additional languages beneficial
- Proven successful project management leadership skills, ability to develop and integrate metrics that demonstrate the value of regulatory affairs to the business.
- Proven expertise in Microsoft Office Suite and government regulatory systems
**Our offer**
- We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles.- Sonova AG
- Laubisrütistrasse 28
- CH-8712 Stäfa
- +41 58 928 01 01
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