Leader Regulatory Affairs (m/w/d)

Lawrence Harvey

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Job ID :

15255


Company Type :

Staffing Firms


Industry :

Medical and Nursing


Education Level :

Other


Address 1 :

Western Europe,Germany,Thüringen,


Key Skills :

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


Salary :

Negotiable


Date Posted :

28 Aug, 2019



Company Name :

Lawrence Harvey


Location1 :

Thüringen




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Leader Regulatory Affairs (m/w/d)

Medical Devices

Thüringen



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



d.perkins@sciproglobal.de



+49 89 2109 4906


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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