Regulatory Affairs Manager – Apac - Diabetes Care (on-site)

Abbott

Alameda, California, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
Diabetes care product portfolio
Apac region regulatory requirements
Cross-functional project teams
This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment

Job Summary

  • This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
  • In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislation in the APAC region.
  • You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region.

Matching Summary

This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Health Investment Plan (HIP) PPO medical plan, retirement savings plan, tuition reimbursement, Freedom 2 Save student debt program, FreeU education benefit

Skills & Requirements

Must-have

  • Diabetes Care product portfolio
  • APAC region regulatory requirements
  • cross-functional project teams
  • medical device or IVD submissions
  • post marketing approval requirements

Nice-to-have

  • career development opportunities
  • health and wellness benefits
  • diversity and inclusion focus

Key Requirements

  • Bachelor's Degree or equivalent
  • 4-5 years regulated industry experience
  • 2-5 years regulatory affairs experience
  • Supervisory experience
  • Working knowledge of APAC standards
  • Strong communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter