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


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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