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Job Details

Global Regulatory Manager - Zurich, Switzerland - Medical Devices

Company: Just Pharma
Reference: SWRAMZ02/17
Closing Date: 07 May 17
Type: Permanent
Salary (£): Competitive

Job Summary:

Just Pharma are currently working with a Global Medical Devices Organisation who are now searching for a Global Regulatory Affairs Manager to join their team in the Zurich Area.


Position Overview 

This role will be responsible for all Regulatory Affairs delverables linked to new product development for assigned products.

Duties & Responsibilities

  • Development and execution of regulatory strategies for assigned development projects within the business unit implant systems
  • Support of product development in cross functional teams
  • Creation, review and/or approval of documents of the design control process
  • Accountable for regulatory compliance
  • Support international product registration
  • Assessment, approval and regulatory implementation of change requests
  • Review and approval of product related labeling and marketing material
  • Support SAP based reporting systems
  • Monitoring legislative environment in relevant markets
  • Training internally on relevant procedures and requirements

?Required Experience

  • Experience with EU, US, AUS and CAN medical Device regulations
  • Experience in preparations for notified body audits and FDA inspections
  • Experience in managing cross functional projects and teams
  • Good knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
  • Good knowledge of product development processes in MD industry
  • Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820

If you would be interested in applying for this position or having a confidential discussion please send a CV to Simon on or call 01707 817 629.


Regulatory Affairs, Regulatory Affairs Manager, RA Manager, RA, Medical Devices, ISO 13485, FDA, 21 CFR Part 820, Zurich, Switzerland

Apply for this job: Global Regulatory Manager - Zurich, Switzerland - Medical Devices

Contact Information:

Address:  Head Office
2nd Floor Albany Chambers, Bridge Road East, Welwyn Garden City, Hertfordshire
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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