Global Regulatory Affairs Lead — Medical Devices

Boston Scientific; Marlboro (MA); On-site; USD 107,000 - 203,000; Full time

Job summary

Boston Scientific is seeking a Regulatory Affairs professional to lead submissions and oversee global regulatory compliance for medical devices within the Urology division. You will collaborate across functions to develop strategies for US, EU, China, and international registrations.

The role requires experience with 510(k), EU MDR, and FDA regulations, plus the ability to coordinate with contract manufacturers and OEM partners. MA location.

Qualifications

• Bachelor’s degree in a scientific, technical, or related field.
• At least 7 years of regulatory affairs experience in medical devices.
• Experience supporting 510(k), EU MDR, and international registrations.
• Knowledge of FDA, EU, and international device regulations.
• Understanding of product development, design controls, and quality systems.

Responsibilities

• Provide regulatory guidance and training to teams.
• Lead submissions strategy, testing requirements, and regulatory pathways.
• Develop regulatory strategies for OEM and contract manufacturers.
• Coordinate global regulatory filings and documentation.
• Review labeling and advertising for regulatory compliance.

Skills

Regulatory affairs

FDA regulations

EU MDR

510(k) submissions

Cross-functional collaboration

Education

Bachelor's degree in a scientific, technical, or related discipline

Tools

Microsoft Office

Job description

Boston Scientific is seeking a Regulatory Affairs professional to lead submissions and oversee global regulatory compliance for medical devices within the Urology division. You will collaborate across functions to develop strategies for US, EU, China, and international registrations.

The role requires experience with 510(k), EU MDR, and FDA regulations, plus the ability to coordinate with contract manufacturers and OEM partners. MA location.