Senior Regulatory Affairs Program Lead (apac) - Abiomed, Inc.

Abiomed, Inc.

Danvers, Massachusetts, United States of America
Base: $109,000.00 - $174,800.00; bonus/equity: not...
Hybrid
Regulatory dossier/sted/database management
Health authority inquiry response
Product development regulatory input
This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission

Job Summary

  • This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission.
  • You will be responsible for creating, maintaining, and updating relevant regulatory dossiers for product registrations, change notifications, or annual reports for Asia Pacific Regions.
  • The anticipated base pay range for this position is $109,000.00 - $174,800.00.

Matching Summary

This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission.

Salary

Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation –120 hours per calendar year, Sick time - 40 hours per calendar year, Holiday pay –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours, Bereavement Leave – 240 hours for immediate family, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours

Skills & Requirements

Must-have

  • Regulatory dossier/STED/database management
  • Health Authority inquiry response
  • Product development regulatory input
  • Manufacturing process change review
  • Regulatory landscape monitoring

Nice-to-have

  • Cross-functional collaboration
  • Scientific/Regulatory writing
  • Asian language proficiency

Key Requirements

  • Bachelor's Degree required
  • 6+ years Regulatory Affairs experience
  • Medical Device/Cardiovascular experience preferred
  • Class III Medical Device submission experience desired
  • Asia and Middle East submission experience desired

Work Rights

Not specified

Tailored Resume

Cover Letter