Regulatory Affairs Manager (m/w/d)

Lawrence Harvey

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Job ID :

15175


Company Type :

Staffing Firms


Industry :

Medical and Nursing


Education Level :

Other


Address 1 :

Western Europe,Germany,Niedersachsen,


Key Skills :

regulatory affairs, medical devices, germany, ISO 13485, medical technology, medical engineering, ri


Salary :

€70000 - €90000 per annum


Date Posted :

07 Aug, 2019



Company Name :

Lawrence Harvey


Location1 :

Niedersachsen




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Regulatory Affairs Manager (m/w/d)

Niedersachsen

Medical Devices

My client located in Niedersachsen is a manufacturer of high-risk medical devices, and are currently searching for a new Regulatory Affairs Manager. The company is a highly innovative start-up, with just over 40 people currently working at the HQ in Germany, which is growing at a rapid rate due to continued success. This position would report directly to the Head of QM/RA, and would be working in close collaboration with the Quality Manager of the same level. For this reason, it would be an amazing time to join and become part of an award winning group, and to be have your say in bringing the company forward even further.

Your Role:

* Monitoring and implementing regulatory requirements both nationally and internationally
* Supervising and implementing nation and international regulatory approval and registration procedures
* Creating and updating legal requirements for the respective target markets, and to prepare country-specific submission documents
* Review and maintain existing registrations
* Communicating with external partners and regulatory authorities
* Supporting international sales in the qualification of distributors
* Supervising registration agencies / distributors during the country specific approval processes
* Monitoring international approval processes
* Organizing and implementing employee training when necessary

Your Profile:

* Successfully completed a degree in medical technology or comparable fields
* Several years of experience working in a regulatory affairs environment, ideally in medical technology
* Experience in the field of approvals for medical devices (class III) on an international scale
* Very strong knowledge of working with Office programs
* High level of commitment, reliability, and team spirit
* Fluency in both English and German


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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