Regulatory Affairs Specialist - Medical Devices (m/f)

Lawrence Harvey

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Job ID :


Company Type :

Staffing Firms

Industry :

Medical and Nursing

Education Level :


Address 1 :

Western Europe,--Munich,München (81249),

Key Skills :

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

Salary :


Date Posted :

13 Apr, 2018

Company Name :

Lawrence Harvey

Location1 :

München (81249)

Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



Regulatory Affairs - Medical Devices m/f


My client located in the Munich area are a pioneer within the Medical Device industry with over 100 years operating in their area of the market. You will have the chance to join a dynamic, motivated group of professionals who all share the same goal to continue the well-established success of the company.

The role:

* Independent and timely creation of registration dossiers for the global approval of the company's medical devices as well as archiving the registration documentation
* The monitoring of existing registrations for timely initiation of re-registration and notification of changes in products on an international basis
* Preparation and evaluation of global registration requirements for internal interfaces and external partners
* Termination of marketing in relation to specific products and countries
* Process responsibility for the item country approval
* Constant updating and archiving of product documentation
* Preparation and updating of the declaration of conformity

Your profile:

* Completed relevant studies In Life Science related fields or equivalent qualifications
* You have previously worked in Regulatory Affairs for Medical Devices and previously performed registrations for Medical Devices (preferably on an international scale)
* Knowledge of international approvals with external partners outside of EU
* FDA approval experience would be a great bonus
* Fluency in English and German both written and spoken

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

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