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Regulatory Affairs Manager - Flurlingen (CH)

Regulatory Affairs Manager - Flurlingen (CH)

Job Title: Regulatory Affairs Manager - Flurlingen (CH)
Contract Type: Contract
Location: Switzerland
Industry:
Salary: Negotiable
Reference: HQ00112710_1576762731
Contact Name: Michael Burgstaller
Contact Email: m.burgstaller@sciproglobal.de
Job Published: December 19, 2019 13:38

Job Description

Our client is a held independent Swiss company founded in 2008.

Since 2016 focused on the development and manufacturing of a product portfolio of stent delivery systems alongside a balloon dilation catheter. The broader view to innovate and improve the concept of endovascular implants - particularly stent and balloon technology - is based on the OEM activity during the first years.

Are you willing to actively support the development and further growth of our company?

These will be your tasks
  • Implement the new MDR in the regulatory processes with MDD taking into account for class II - III medical devices
  • Prepare international submissions
  • Develop and write clear arguments and explanations for new product certifications and license renewals
  • Monitor and set timelines for certification and/or license variations and renewal approvals
  • Collect, collate and evaluate scientific data that has been researched by colleagues
  • Provide input to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets assigned
  • Provide regulatory intelligence information to the organization
  • Monitor the regulatory competitor landscape and keep the organization abreast of potential threats and opportunities jeopardizing global development goals
  • Stay abreast of current and new legislation related to medical devices
You're Offering These Qualifications
  • Master's degree in scientific discipline such as biology, chemistry, engineering or equivalent
  • 5 - 10 years' experience in general regulatory affairs, with at least 4 years of international regulatory experience
  • Profound experience with international medical device (class II & III) regulatory approvals and submissions
  • In depth knowledge on the new MDR and on all international regulations
  • Familiar with the medical device and combination device European regulations (93/42/CE and 2001/83/CE)
  • Strong understanding of international regulatory landscape & required approaches and strategies
  • Agility to handle and deliver on a multitude of projects, programs, and priorities paired with high sense for execution and teamwork
  • Collaborative, empathic and solution-oriented individual
  • Excellent command of spoken and written English and German, any other language is an asset

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