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

Johnson & Johnson MedTech

Danvers, Massachusetts, United States
Base: $109,000.00 - $174,800.00; bonus/equity: not...
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Regulatory submission management
Cross-functional collaboration with r&d and quality
Regulatory dossier and sted database maintenance
** Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead for their Abiomed business, located in Danvers, Massachusetts. The position requires a strong background in regulatory affairs, particularly within the medical device industry, and offers a hybrid work schedule with a focus on compliance and effective communication across teams. **

Job Summary

  • Johnson & Johnson is committed to an inclusive work environment respecting diversity and dignity of employees worldwide.
  • This role supports the APAC unit of Abiomed business, working closely with in-country regulatory representatives to ensure efficient regulatory submissions.
  • Employees are eligible for comprehensive benefits including retirement plans, various leave types, and parental leave.

Matching Summary

Match Score: 75

** Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead for their Abiomed business, located in Danvers, Massachusetts. The position requires a strong background in regulatory affairs, particularly within the medical device industry, and offers a hybrid work schedule with a focus on compliance and effective communication across teams. **

Salary

Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Retirement plans, vacation, sick time, parental leave, and other paid leaves

Skills & Requirements

Must-have

  • Regulatory submission management
  • Cross-functional collaboration with R&D and Quality
  • Regulatory dossier and STED database maintenance
  • Regulatory compliance for medical devices
  • Health Authority inquiry response
  • Hybrid work schedule with onsite presence

Nice-to-have

  • Fluency in Asian languages
  • Scientific and regulatory writing skills
  • Experience with Asia and Middle East markets
  • Strategic regulatory planning
  • Coaching and communication skills

Key Requirements

  • Bachelor’s degree required, advanced degree preferred
  • 6+ years regulatory affairs experience, 4+ with advanced degree
  • Experience with Class III medical device submissions
  • Experience with Asia and Middle East regulatory submissions
  • Strong communication and scientific writing skills
  • Ability to work cross-functionally

Work Rights

Must be located within commutable distance of Danvers, MA; No remote option

Tailored Resume

Cover Letter