Senior Regulatory Affairs Specialist - Medical Devices & Software

Boston Scientific; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific Corporation in Maple Grove, MN, is seeking a Senior Regulatory Affairs Specialist to drive regulatory strategy and submissions for SEISMIQ console products. You will collaborate across systems, software, hardware, cybersecurity, and quality teams to maintain global approvals through the product lifecycle.

The role requires strong regulatory knowledge, experience with 510(k)/PMA, EU MDR knowledge, and the ability to manage multiple deliverables in a fast-paced, hybrid work

Qualifications

• Bachelor’s degree in a scientific, engineering, or related technical discipline.
• Minimum five years of experience in Regulatory Affairs or a related medical device discipline, or minimum three years with an advanced degree.
• Direct regulatory experience with capital equipment, reusable electromechanical systems, energy-delivery devices, or software-enabled medical devices.
• Working knowledge of US/EU medical device regulations, including FDA submissions, EU MDR, QMS, and change assessment principles.
• Hands-on experience preparing or supporting regulatory submissions and technical documentation for Class II and Class III devices.
• Experience across the medical device lifecycle including design controls, risk management, verification/validation, manufacturing, and change control.
• Ability to independently manage defined regulatory workstreams and escalate complex matters.

Responsibilities

• Develop and implement US, EU, and international regulatory strategies for console products and system-level changes.
• Prepare, coordinate, author, and maintain regulatory submissions and documentation (510(k), PMA, EU MDR tech docs).
• Serve as Regulatory Affairs representative on cross-functional teams and provide regulatory feedback throughout design and post-market activities.
• Assess changes for regulatory impact and document filing recommendations.
• Collaborate with cross-functional teams to ensure complete, consistent submission content.
• Review documentation for regulatory readiness including software, cybersecurity, and labeling.

Skills

Analytical skills

Technical writing

Communication skills

Organizational skills

Education

Bachelor’s degree in a scientific, engineering, or related technical discipline

Advanced degree in related discipline

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

Boston Scientific Corporation in Maple Grove, MN, is seeking a Senior Regulatory Affairs Specialist to drive regulatory strategy and submissions for SEISMIQ console products. You will collaborate across systems, software, hardware, cybersecurity, and quality teams to maintain global approvals through the product lifecycle.

The role requires strong regulatory knowledge, experience with 510(k)/PMA, EU MDR knowledge, and the ability to manage multiple deliverables in a fast-paced, hybrid work