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Regulatory Affairs Specialist

  • Gehalt: CHF72 - CHF82 per hour
  • Art der Stelle: Contract, Full-time
  • Ort: Zuchwil
  • Berufsbereich: Pharma & Life Sciences
  • Datum der Ausschreibung: 04.06.2018
  • Job ID: J387502ASVT-040618
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Regulatory Affairs Specialist - Zuchwil (near Solothurn) - 100%

Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.

For our international client based in Zuchwil, Experis is currently looking for a Regulatory Affairs Specialist for a contracting position until, at least, the end of 2018.

General information:

- Start date: ASAP
- End date: 31.12.2018
- Work location: Zuchwil
- Workload: 100%


Tasks & Responsibilities:

Support the internal Regulatory Affairs group in creation and maintenance of technical documentation supporting compliance to the European Council Directive 92/42/EEC or Regulation 2017/745.

  • Ensuring that the company's products comply with the regulations set up by government agencies
  • Advising engineering and manufacturing on regulatory requirements
  • Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
  • Creation, review and maintenance of regulatory related technical documentation
  • Capturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scale
  • Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials
  • Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
  • Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
  • Providing progress of work-plans and the status of key project deliverables
  • Follow the quality standards and regulatory requirements

You bring for this role the following qualifications:

  • 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
  • Strong knowledge of ISO 13485 and ISO 9001, QSR Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745
  • Reasonable knowledge of FDA requirements registration
  • Strong understanding of Risk Management process, label and labeling, change management is desired
  • International experience preferred
  • Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
  • Strong knowledge and skills in MS Office
  • Familiarity with Technical Documentation structure according to STED required
  • English spoken and written (German would be a plus)

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt on +41 61 282 22 16.

Even though this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland.

Check out all of Experis' job openings at www.experis.ch or visit my personal page https://www.experis.ch/stephanie-vogt and connect to me on www.linkedin.com/in/stephanie-vogt2

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