Head of Regulatory Affairs

vor 1 Woche

Zurich, Schweiz Proclinical Vollzeit

**Responsibilities**:

- Handle integrated quality systems with ISO 13485/9001/14001/45001/17025, as well as ISO 50001 would be advantageous.
- You will manage EU IVDR roll out in a global analytical instrumentation corporation - from approval process to daily improvements and managing audits.
- Guide and develop a team of around 20 professionals within 3 countries for QA, Regulatory Affairs and Environment, Health & Safety.
- Guarantee global product compliance in a pro-active and rational manner.

**Skills & Requirements**:

- Educated to a degree level in a pertinent discipline.
- Several years of experience within a medical device organisation such as an MD or IVD within a field of quality and/or regulatory affairs.
- Leadership abilities, globally as week as cross-country.
- Fluency in the English language with knowledge in German and/or French.
- Presentation and training capabilities.
- Communication skills both verbally and in writing towards a varied audience.
- Able to prioritise workload.
- Capable of managing various project simultaneously within a fast-paced setting.
- Willing to travel for business needs.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-JV2

QACompliance

  • Head of Regulatory Affairs

    Vor 6 Tagen

    Zurich, Schweiz Global Kader Personal Vollzeit

    **INTRODUCTION**: - For our client, a Swiss pioneer in ESG data science located in Zurich, we are looking for an individual as **Head of Regulatory Affairs**: - (Full time, unlimited contract) The earliest start date is as soon as possible. **ASSIGNMENT DESCRIPTION**: - Define a regulatory affairs strategy and articulate a business plan, including...

  • Head of Regulatory Affairs and Sustainability

    vor 2 Wochen

    Zurich, Schweiz RAHN AG Vollzeit

    Founded in 1940, based in Switzerland and family-owned RAHN-Group is renowned for exceptional products and outstanding innovative solutions. We are internationally active on the market with specialty chemicals for EnergyCuring, with high-quality active ingredients and special products for the Cosmetic industry. Years of experience, know how and competent...

  • Head of Integrity and Regulatory Affairs

    vor 2 Wochen

    Zurich, Schweiz ABB Vollzeit

    **Head of Integrity and Regulatory affairs**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....

  • Regulatory Affairs Coordinator

    Vor 2 Tagen

    Zurich, Schweiz Pfizer Vollzeit

    Weltweit arbeiten die Mitarbeiter von Pfizer gemeinsam daran, die Gesundheit eines jeden Einzelnen überall zu verbessern. Während wir Arzneimittel und Medizin-Produkte entwickeln und unser Geschäft global ausweiten, halten wir jederzeit Ausschau nach neuen Talenten. Derzeit suchen wir Sie an unserem Standort in Zürich als: Regulatory Affairs Coordinator...

  • Director, Global Regulatory Affairs Cmc

    vor 5 Stunden

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Join Takeda as a Director, Global Regulatory Affairs (GRA) CMC, where you will lead GRA CMC Due Diligence in partnership with organizational and external stakeholders. You will ensure the communication/development of regulatory CMC risks and strategy, develop best practices that enable CMC due diligence, ensuring that a given compound meets technical and...

  • Junior Regulatory Affairs Manager

    vor 2 Wochen

    Zurich, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Head of Medical Affairs, Europe

    vor 2 Wochen

    Zurich, Schweiz Genmab Vollzeit

    At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Zurich, Schweiz Sonova Vollzeit

    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...

  • Manager Regulatory Affairs

    vor 2 Wochen

    Zurich, Schweiz Hays (Schweiz) AG Vollzeit

    # Manager Regulatory Affairs # (m/f/d) Freelance/temporary employment for a project Zurich Start date: asap Reference number: 852381/1 ### Responsibilities ### * Lead regulatory activities for vaccine projects, including submissions and lifecycle management * Prepare and manage Marketing Authorization Applications (MAA) and variations in compliance with EMA...

  • Junior Regulatory Affairs Manager

    Vor 6 Tagen

    Zurich, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...