Specialist Ii, Product Surveillance

jobs.abbott

Penang, Malaysia
Base: n/a; bonus/equity: not specified; benefits: ...
Not specified
21 cfr part 820 compliance
21 cfr part 803 reporting
Customer complaint investigation
The Specialist II, Product Surveillance position at Abbott in Penang, Malaysia involves documenting and investigating customer complaints related to medical devices, ensuring compliance with regulatory standards, and collaborating with various healthcare professionals. The role requires strong communication skills and the ability to manage multiple tasks effectively

Job Summary

  • The role involves documenting, investigating, and correcting field-related problems while managing customer complaints through a Quality Systems Database.
  • Employees must ensure strict compliance with FDA regulations including 21 CFR Part 820 and 21 CFR Part 803.
  • The position requires communicating findings to R&D engineers and business unit managers to drive product enhancements.

Matching Summary

Match Score: 75

The Specialist II, Product Surveillance position at Abbott in Penang, Malaysia involves documenting and investigating customer complaints related to medical devices, ensuring compliance with regulatory standards, and collaborating with various healthcare professionals. The role requires strong communication skills and the ability to manage multiple tasks effectively.

Salary

Base: N/A; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 820 compliance
  • 21 CFR Part 803 reporting
  • Customer complaint investigation
  • FDA regulatory requirements
  • Quality Systems Database management

Nice-to-have

  • Strong multitasking skills
  • Collaborative communication style
  • Trend analysis capabilities

Key Requirements

  • Knowledge of FDA medical device regulations
  • Experience with quality systems databases
  • Ability to author correspondence to customers

Work Rights

Not specified

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