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Regulatory Affairs Specialist

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Varian is the world’s largest manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy and brachytherapy. Our vision is a world without fear of cancer. To meet this challenge, we equip the world with new tools for fighting cancer.

At our R&D site in Dättwil, Switzerland, with more than 250 employees, mostly engineers, computer scientists and physicists we specialize in the development of imaging software and hardware as well as treatment management systems for radiation therapy cancer treatment. Bring your talent to a place where your work will help fight cancer. Join Varian’s Oncology Systems team, and the work you do can make a difference by helping to create a world without fear of cancer.

Regulatory Affairs Specialist

 As Regulatory Affairs Specialist at Varian you are accountable for the coordination and preparation of document packages for regulatory submissions from all areas of company as well as audits and inspections. You compile all materials required in submissions, license renewal, and annual registrations and maintain regulatory compliance for our products. You keep abreast of regulatory procedures and changes, may interact with regulatory agencies on defined matters, and recommends strategies for earliest possible approvals of clinical trials applications.

 

Specific Responsibilities

  • Coordinate the efforts associated with the preparation of regulatory documents for international regulatory submissions
  • Prepare and maintain technical files and certificates as necessary to obtain and sustain product approval
  • Communicate with regulatory agencies and testing laboratories regarding submissions, compliance test requirements and testing, and follow-up of submissions under review
  • Advise engineering project teams and manufacturing on regulatory and labeling requirements
  • Extend and maintain the knowledge on existing and emerging international and local regulations, standards, or guidance documents
  • Conduct gap analysis for new standards and regulations
  • Escort government inspectors during inspections and provide pre- and post-inspection follow-up information
  • Analyze product complaints and make recommendations regarding their reportability

 

 

Desired Qualifications

  • Master in mathematics, physics, electrical engineering or related degree
  • Master's degree in medical physics, engineering, or related technical field with comparable educational background
  • Experience in standards and government regulations applicable to medical devices, preferably in radiation emitting devices and wireless communication
  • Experience of working and communicating with different regulatory authorities and corresponding relationships
  • Fluence in English, written and verbal

You are analytical, communicative and focused. You work structured and have an eye for details. In addition, you can express your ideas and research in written form. You are used to working independently, open to discussing ideas and solutions with your colleagues. You thrive in an international work environment and in cultivating your contacts with partners in Europe and overseas.

Have we sparked your interest in a challenging and exciting position in a global environment with a potential for development? We look forward to receiving your application and CV. Job Code 15945BR. APPLY HERE

www.varian.com/ch/daettwil

Baden / Steinhausen / Villigen / Steinhausen (ZG)

Gesamtbewertung

5,0

Basierend auf 1 Bewertungen

4,0 Karriere / Weiterbildung
5,0 Gehalt / Sozialleistungen
2,0 Work-Life-Balance
4,0 Management

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