Regulatory Affairs - Quality Manager (w-m) Munich

Lawrence Harvey

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,Germany,München (80335),

Key Skills :

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

Salary :


Date Posted :

04 May, 2018

Company Name :

Lawrence Harvey

Location1 :

München (80335)

Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:

upto 50%


Regulatory Affairs - Quality Manager (m-f)

Medical Devices


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

Company Name:

Lawrence Harvey


150 Leadenhall Street,London


Staffing Firms


United Kingdom





100 - 499


Pharmaceutical Recruitment



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

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