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Regulatory Affairs Manager
vor 3 Monaten
Überblick:
Workload:
%
Place of work:
Fällanden, Switzerland
Department:
Quality and Regulatory Affairs
Start of contract:
Immediately or by agreement
Aufgaben/Verantwortlichkeiten:
- 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 daytoday support of internal stakeholders (e.g., for performance studies) and execution of UDI implementation, multicountry registrations and postmarketsurveillance activities.
- Ensure international product compliance of medical devices (IVDs) in a proactive and pragmatic, but always compliant way
Qualifikationen:
- Academic degree in a relevant field
- Proven multiyear 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 crosscountry 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 IVDrelated projects in a fastpaced environment
What we offer
- Home office possibility with 41.5 hours per week
- Futureoriented 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 inhouse fitness studio
- Work location with local recreation area (Greifensee)
- Our staff restaurant "Food Spin" with freshly prepared menus and buffet every day
