Regulatory Affairs Manager
vor 3 Wochen
Présentation:
Workload: 80 - 100%
Place of work: Fällanden, Switzerland
Department: Quality and Regulatory Affairs
Start of contract: Immediately or by agreement
Responsabilités:
- Team member in a team of 5 Regulatory Affairs professionals, positioned in several countries, with Production Sites close to Zurich CH (manufacturer site), Karlsruhe GER and Strasbourg FR (some travel required; remote work option with 2 days out of 5 home office)
- IVD (e.g., EU IVDR) compliance roll out in an international analytical instrumentation life sciences company - from approval process (e.g., TechDoc review) to day-to-day support of internal stakeholders (e.g., for performance studies) and execution of UDI implementation, multi-country registrations and post-market-surveillance activities.
- Ensure international product compliance of medical devices (IVDs) in a pro-active and pragmatic, but always compliant way
Qualifications:
- Academic degree in a relevant field
- Proven multi-year experience in the medical device (MD or IVD) or life sciences industry in the field of quality and/or regulatory affairs
- Proven project management skills, international and cross-country exposure a plus
- Fluent in English including presentation and trainer skills, German and/or French a plus
- Ability to interact and align with various stakeholders - from Board level to peer groups
- Strong track record in prioritizing and simultaneously managing and/or supporting multiple IVD-related projects in a fast-paced environment
**What we offer**
- Home office possibility with 41.5 hours per week
- Future-oriented and diverse company with modern workplaces
- At least five weeks of vacation and additional days off
- Free parking garage on the company premises
- Cost absorption of the SBB Half-Fare Card
- Good social benefits and insurance
- Diverse opportunities for further development in Switzerland and globally
- Promotion of health and sports with various initiatives and an in-house fitness studio
- Work location with local recreation area (Greifensee)
- Our staff restaurant "Food Spin" with freshly prepared menus and buffet every day
**Who we are
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