Senior Regulatory Affairs Specialist - Endoscopy

Boston Scientific Foundation Inc

Marlborough, MA, US
Minimum salary: $89,200; maximum salary: $169,500;...
On-site
Develop regulatory strategies
Support new business development
Global compliance
At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions

Job Summary

  • At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions.
  • This role in Regulatory Affairs will be responsible for developing regulatory strategies and providing support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers.
  • This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Matching Summary

At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions.

Salary

Minimum Salary: $89200; Maximum Salary: $169500; Benefits: See www.bscbenefitsconnect.com

Skills & Requirements

Must-have

  • Develop regulatory strategies
  • Support new business development
  • Global compliance
  • US, EU, China regulatory filings
  • Product development lifecycle support
  • Review device labeling and advertising

Nice-to-have

  • Advancing skills and career
  • Diverse and high-performing employees
  • Problem-solver with imagination
  • Nurturing diverse and inclusive workplace

Key Requirements

  • Bachelor’s degree or equivalent work experience
  • Minimum of 4 years' experience in Regulatory Affairs
  • Medical device industry experience
  • FDA, EU MDR, and international regulations knowledge
  • Prior experience with 510(k) submissions
  • Prior experience with EU MDR
  • Prior experience with China and international regulatory requirements
  • Fluent in Mandarin

Work Rights

Not specified

Tailored Resume

Cover Letter