Regulatory Affairs Manager - Flurlingen (CH)

Lawrence Harvey

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Job ID :

15493


Company Type :

Staffing Firms


Industry :

Health and Safety


Education Level :

Master of Science


Address 1 :

Western Europe,Switzerland,Switzerland,


Key Skills :

Regulatory Affairs, MDR, IEC 60601, Medical Devices 510 (k),


Salary :

Negotiable


Date Posted :

19 Dec, 2019



Company Name :

Lawrence Harvey


Location1 :

Switzerland




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





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

My Contact:

* E-Mail: m.burgstaller@sciproglobal.de
* Tel: +41 43 508 92 17
* Xing: https://www.xing.com/profile/Michael_Burgstaller19/cv




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