Regulatory Affairs Specialist

jobs.abbott

Taipei, Taiwan
Not specified; not specified; not specified
2 years md/ivd industry experience
Regulatory submissions management
Labeling and product information review
The role is responsible for managing new and variation registrations to secure approvals efficiently

Job Summary

  • The role is responsible for managing new and variation registrations to secure approvals efficiently.
  • Candidates must oversee lifecycle activities including renewals, notifications, and product withdrawals.
  • The position requires identifying regulatory risks and proposing mitigation strategies for supply constraints.

Matching Summary

The role is responsible for managing new and variation registrations to secure approvals efficiently.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 2 years MD/IVD industry experience
  • regulatory submissions management
  • labeling and product information review

Nice-to-have

  • local study execution experience
  • clinical evaluation for Class III IVDs
  • cross-functional communication skills

Key Requirements

  • Minimum 2 years MD/IVD regulatory experience
  • Project management skills
  • Experience with Class III IVDs preferred

Work Rights

Not specified

Tailored Resume

Cover Letter