Leader Regulatory Affairs (m/w/d)

Lawrence Harvey

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Job ID :


Company Type :

Staffing Firms

Industry :

Medical and Nursing

Education Level :


Address 1 :

Western Europe,Germany,Thüringen,

Key Skills :

regulatory affairs, medical devices, IVD, quality, quality management, IVD, ISO 13485

Salary :


Date Posted :

28 Aug, 2019

Company Name :

Lawrence Harvey

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



Leader Regulatory Affairs (m/w/d)

Medical Devices


My client located in Thüringen is an international medical technology manufacturer, who offer a wide range of unique and innovative products to the global market. You will have the opportunity in this role to step into a leading position that offers an attractive salary, internal and external training, flat hierarchies and short decision paths. This will most certainly be a positively challenging task in a forward-thinking company.

Your Role:

* Leading a team of 6/7 (RA / QM / QS)
* Ensuring an effective implementation of DIN EN ISO 13485, MDR
* Continuous development of the QMS
* Creation and maintenance of the technical documentation, taking into account the applicable standards and guidelines (medical devices class I-IIb)
* Planning, coordination and implementation of national and international approvals for medical devices
* Participation in product development/project management and in the product life-cycle with regulatory topics
* GAP analysis for changes to standards, including the definition of measures
* Participation in the planning, implementation and evaluation of clinical studies

Your Profile:

* Successfully completed studies in a technical of life science related field
* At least 3 years professional experience within Regulatory Affairs for medical devices (or Quality Management/Assurance)
* Sound knowledge of the medical device industry as well as the relevant standards/guidelines
* Strong leadership skills


+49 89 2109 4906

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 www.lawrenceharvey.com.

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