MDSAP Technical Pack Reviewer

  • Full-time

Company Description

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

We are 100% committed to helping you reach your full potential. Be the professional you want to be with SGS. Be 100% you.

Job Description

  • Conduct reviews of MDSAP reports and approve or raise queries based on technical and procedural knowledge
  • Ensure that reviews are technically sound and in compliance with all applicable regulations, standards, guidelines and Competent Authority expectations
  • Review MDSAP audit packs according to specified requirements
  • Generate Query Sheets for any noted deficiencies in the MDSAP audit pack
  • Review and accept/reject query corrections
  • Submit final approved documents to the Global MDSAP administrator for submission to REPS
  • Submit final approved document to Applaudd and approve the MDSAP pack
  • Approve MDSAP certificates after technical approval.
  • Determine final approval for MDSAP audit packages and the issue of MDSAP certificates
  • Signature authority for final MDSAP reports and NGE
  • Ensure that the highest level of service is provided through efficient service delivery and that customer requirements are met
  • Ensure adherence to SGS Policies, procedures and processes
  • As a member of the Global Medical Device office (MDO) to minimize risks associated with medical device certification.

Qualifications

  • 4 years experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research and two years shall be in the design, manufacture, testing or use of the device or technology related
  • Experience in codes and previous Technical File review
  • Bachelor's Degree in medicine, pharmacy, engineering or other relevant sciences
  • Good communication techniques through electronic mediums
  • Good written English skills 

Additional Information

As a caring company, SGS not only offers a competitive remuneration package but also offers staff caring items to the right candidate, including:

  • 5-day Work Week 
  • Double Pay and Performance Bonus
  • Dental and Medical Benefits
  • Life Insurance
  • Annual Leave
  • Birthday Leave
  • Paid Maternity Leave, Paternity Leave, and Marriage Leave
  • On-the-Job Training 
  • Education and Training Subsidies
  • Transportation Subsidies
  • Shuttle Bus Service
  • Employee Assistance Program (EAP)
  • Career Advancement Opportunities
  • Staff Activities
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