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Job Details

Global Regulatory Manager - Zurich, Switzerland - Medical Devices

Company: Just Pharma
Location:
Reference: SWRAMZ02/17
Closing Date: 17 Apr 17
Type: Permanent
Salary (£): Competitive
Benefits:

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.

Requirements:

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 simon@justpharma.co.uk 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
AL7 1HL
England
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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