Regulatory Labelling Manager (m/f) in the Area of Zug

Lawrence Harvey


Job ID :

7212


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,Switzerland,Zug,


Key Skills :

Labeling, Regulatory Affairs, Engineer, Switzerland, Medical Devices, Healthcare, Quality


Salary :

Negotiable


Date Posted :

17 May, 2017



Company Name :

Lawrence Harvey


Location1 :

Zug




Job Category :

Healthcare Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

100.00%





Description

Regulatory Labelling Manager (m/f) in Baar

Our clients is an internationally leading Medical Technology Company who offers an exciting tailored career path for your professional and personal development within their Regulatory Affairs & Quality Assurance team. The client is specialized on heart diagnosis, monitoring as well as software solutions. The manufacturing takes place in Switzerland and the products are distributed worldwide.



Tasks:

* Coordinating global regulatory affairs functional activities to ensure effective support to achieve existing plans and objectives
* Manage and be responsible for regulatory label compliance e.g. UDI requirements
* Manage international regulatory submission process through to approval, including management and coordination of preparation of all regulatory documentation
* Close cooperation with local regulatory representative e.g. in Asia Pacific region and Latin America for product registration
* Support distributors world-wide for product registration
* Involved into change assessment process
* Be a part of review process for labelling and marketing documents
* Support regulatory training
* Keep up-to-date with the current regulatory environment (medical device)

Requirments:

* Fluent in English, German is a plus
* Experienced in international medical device environment and familiar with active medical devices
* In-depth know-how of regulatory labelling including UDI
* Experienced with CE-marking and international registration process. FDA 510(k) and PMA submission, experience is a plus
* Good organizational and planning skills
* Good communication skill with local regulatory representatives and distributors

Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de

In case of any further question, please do not hesitate to contact
Petra Ognjenovic: 0049 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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