Senior Product Quality & Regulatory Analyst

Boston Scientific; Marlborough (MA); Hybrid; USD 97,000 - 184,000; Full time

Job summary

Boston Scientific is seeking a Principal Product Analyst to advance product quality and patient safety across our global organization. You’ll lead complaint handling and regulatory reporting activities and drive cross-functional initiatives that strengthen our post-market quality system.

This highly visible role requires systems-thinking, project management, analytical problem-solving, and strong communication skills.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum of 8 years' experience in the medical device industry.
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint and Visio.
• Working knowledge of FDA, ISO and MDR regulations in the medical device industry.
• Demonstrated project management experience.
• Ability to travel up to 5% of the time.

Responsibilities

• Understand and ensure compliance with U.S. and outside-U.S. regulatory requirements for medical device complaint handling and regulatory reporting.
• Lead large, high-impact projects within the Global Quality Community to improve post-market quality across multiple divisions.
• Coordinate concurrent project activities and facilitate collaboration among multisite, cross-functional stakeholders to achieve project deliverables and timelines.
• Communicate project deliverables, milestones and timelines clearly and effectively to senior leadership.
• Influence change and align stakeholders to drive informed decision-making in situations with limited information.
• Provide audit support during front-room and back-room activities.
• Serve as a positive cultural leader by modeling high-quality work, effective communication, resilience and solution-oriented thinking.
• Utilize data and analytics to identify risks, opportunities and business priorities.

Skills

Project management

Regulatory compliance

Data analytics

Communication

Education

Bachelor's degree in scientific/engineering/technical discipline

Tools

SAS

Snowflake

Visio

Job description

Boston Scientific is seeking a Principal Product Analyst to advance product quality and patient safety across our global organization. You’ll lead complaint handling and regulatory reporting activities and drive cross-functional initiatives that strengthen our post-market quality system.

This highly visible role requires systems-thinking, project management, analytical problem-solving, and strong communication skills.