Posted to MedZilla on 4/28/2017


ProClinical

Switzerland, Regulatory Affairs Specialist RA_PD_11604-MZ


 
 

This Regulatory Affairs Specialist job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in Switzerland. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.

Job Role:

  • Drawing on relevant expertise and information from internal and external sources, make a major contribution towards the preparation of regulatory documentation (e.g. Technical Files).

Job Responsibilities:

  • Support the internal Regulatory Affairs group in creation and maintenance of Technical File documentation
  • Reviewing of Risk Management Documentation according to EN ISO 14971:2012 with respect to regulatory regulatory requirements.
  • Reviewing of labeling and promotion material for accuracy and consistency.
  • Ensuring that the company's products comply with the regulations of government agencies, including but not limited to:
  • Keeping abreast of international legislation, guidelines and customer practices.
  • Collecting and collating a wide range of information.
  • Keeping up to date with a company's product range.
  • Developing and writing clear arguments and explanations for regulatory documentation
  • Advising scientists and manufacturers on regulatory requirements.
  • Reviewing change requests
  • Reviewing, preparing and coordinating documentation.
  • Reviewing company practices and providing advice on changes to systems.

Role Requirements:

Expertise of Regulatory Affairs, including:

  • Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
  • Experience with Risk Management documentation for medical devices according to EN ISO 14971:2012
  • Prior Synthes experience preferable (working knowledge of Windchill, Agile, SAP etc)
  • Degree or equivalent in a Life Science.
  • 2-3 years of experience in medical device 
  • Familiarity with Technical Documentation structure according to STED
  • Technically versed in computer software such as MS Word, Excel, Powerpoint,
  • Strong database skills (Access) desired.
  • Strong analytical skills and network thinking
  • Be able to demonstrate driving partnerships within the industry.
  • Proven ability of interpreting legislation and impact to meet commercial needs.
  • Proven capability of successful working relationships with regulatory bodies.
  • Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions. 
  • Excellent communicator, both verbal and written.
  • Excellent command of English and German.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.