Regulatory Affairs - Quality Manager (w-m) Munich

Lawrence Harvey


Job ID :

11374


Company Type :

Staffing Firms


Industry :

Engineering


Education Level :

Other


Address 1 :

Western Europe,Germany,München (80335),


Key Skills :

Regulatory Affairs,ISO 13485, Pharmaceuticals, Medical Devices, CMC, Pharma, Senior Regulatory Affa


Salary :

Negotiable


Date Posted :

04 May, 2018



Company Name :

Lawrence Harvey


Location1 :

München (80335)




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 50%





Description

Regulatory Affairs - Quality Manager (m-f)

Medical Devices

Munich



My client located in Munich is a leader within an industry that is revolutionizing manufacturing. Located in Munich you will experience a start-up environment that is within a leading global technology group. If you are interested in joining a dynamic, forward thinking and driven team, then look no further.



The Role-

* Identification of worldwide Regulatory requirement and relevant standards for the company's medical devices and processes
* Responsible of registrations, certifications and communications with regulatory authorities along with submitting master files to FDA
* Define and coordinate alignment in QMS between certified facilities worldwide
* Collaboration with local Quality Managers as well as R&D and manufacturing activities such as V&V plans
* Collaboration with application engineers and customers to define regulatory requirements, strategies and plans, as well as technical documentation
* Training of application engineers and local quality managers on changes in requirements
* Planning for audit programs for Iso 13485 facilities and sub-contractors
* Participate in manufacturing audits



Your Profile-

* Obtained a degree in engineering or another relevant field
* Over 5 years first hand work experience in RA & QM for Medical Devices
* At least 3 years leading experience
* Experience with FDA, Health Canada, MDD-MDR
* Regulatory experience with all classes of devices
* Strong communication skills, self-motivated, with a positive mind set
* Fluent in English both written and spoken, and other languages would be a bonus



If you are, or know anyone within your network that matches the requirements underlined in this description and you think you have what it takes to join this fantastic organization then please either send your application in response to this advert or alternatively send your CV and cover letter directly to d.perkins@sciproglobal.de


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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