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Regulatory Affairs Specialist, Med Dev. Germany, Munich - S

Employer
ClinChoice
Location
Germany, Munich
Salary
Competitive
Start date
27 Aug 2020
Closing date
26 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
Job Title: Regulatory Affairs Specialist, Medical Devices

Location: Germany - Munich area

Schedule: Permanent - Full time - Office based (some flexibility to work from home occasionally)

TalentSource Life Sciences is currently recruiting a permanent hire for Regulatory Affairs Specialist to strengthen the team of one of our clients.

Our client is a global provider of innovative solutions for life science companies to improve diagnostics, monitoring, hemodynamic solutions and therapy guidance for critically ill patients and patients at risk.

Main Job Tasks and Responsibilities

  • Creation and maintenance of technical documentation for medical device approvals in the European and international markets
  • Research of international regulatory requirements and guidelines for relevant changes
  • Execution of European and international medical device approval and registration procedures
  • Processing of approval and registration amendments
  • Advise colleagues on regulatory implications for product development, testing, and manufacturing projects
  • Communication with internal and external parties
  • Active participation in cross-functional and international projects

 


Education and Experience

 

 

  • A university degree in life sciences or medical technology (e.g. chemistry, biology, pharmacy, medicine or optics) or a long-standing background in the healthcare industry is required
  • Preferably with medical device experience
  • Very good knowledge of English (other languages are an advantage)
  • Attention to detail
  • Analytical thinking with good problem solving skills
  • Ability to act in a multicultural and cross-functional environment
  • Flexibility and high commitment
  • Knowledge of Windows and Office is expected

 


About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002165

or please contact Alexander.Sourounis@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Regulatory Affairs Specialist, medical devices

Skills: Medical Devices, Regulatory, Regulatory Operations Location: Germany, Munich Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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