Senior Product Complaint Analyst

Boston Scientific•Rochester, MN

11d•Hybrid

About The Position

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. Everyone at Boston Scientific works toward one goal: transforming lives by addressing the most critical challenges in the medical device industry. Patient care is at the heart of everything we do, and ensuring quality, compliance and positive outcomes is essential to delivering on that commitment. As a Senior Product Complaint Analyst, you will be a key member of a high-performing team committed to advancing product quality, patient safety and regulatory compliance across global markets. In this role, you will evaluate and investigate customer complaints, prepare Medical Device Reports (MDRs) and Medical Device Vigilance (MDV) submissions, and support post-market surveillance activities within the Cardiac Diagnostics Complaint Management Team. Working closely with cross-functional partners, you will help resolve complex product and quality issues while ensuring timely, accurate and compliant complaint handling. You will play a critical role in maintaining compliance with Good Manufacturing Practices (GMPs), divisional Standard Operating Procedures (SOPs), Work Instructions (WIs), and applicable global regulatory requirements, including 21 CFR Part 820, EU MDR, MDSAP and ISO 13485. By leveraging data-driven insights and analytical problem-solving skills, you will identify emerging trends and risks, drive continuous process improvements, and support informed business and regulatory decision-making. This is an exciting opportunity to make a meaningful impact on health care outcomes worldwide while contributing to a collaborative, innovative and mission-driven culture that values professional growth, teamwork and shared success.

Requirements

Bachelor's degree in a scientific, technical or related discipline.
Minimum of 5 years' experience in complaint handling, post-market surveillance, quality, regulatory affairs or a related function within the medical device industry.
Proficiency with Microsoft Office applications, including Word, Excel and PowerPoint.
Working knowledge and practical application of FDA, ISO and other applicable medical device regulations.

Nice To Haves

Experience supporting corrective and preventive action (CAPA) activities.
Experience handling complaints for medical device products.
Strong research, communication and presentation skills.
Strong technical writing, editing and documentation skills.
Ability to work independently with minimal direction or supervision.
Demonstrated ability to adapt to changing priorities and contribute effectively in a dynamic environment.
Experience using data analytics to support quality, compliance or business decision-making.
Proven ability to influence cross-functional stakeholders and drive process improvements.
Experience presenting recommendations and project updates to leadership audiences.

Responsibilities

Promote a culture of quality, accountability, collaboration and continuous improvement.
Review complaints and regulatory assessments to determine reportability, compliance and potential impact on patient safety and product quality.
Investigate complaints by gathering and analyzing information from clinical staff, field representatives, internal stakeholders and laboratory evaluations.
Establish regulatory reporting decisions using hazard analyses, DFMEAs, investigation findings and regulatory decision models.
Author and submit MDRs, MDVs, MedWatch reports and other regulatory submissions in accordance with global regulatory requirements.
Apply and review complaint coding to support accurate product performance trending, and collaborate with engineering, laboratory and cross-functional teams on investigation outcomes.
Prepare clear, concise written communications summarizing complaint investigations, clinical assessments, product analyses and corrective actions.
Serve as a subject matter expert for complaint handling, product performance and regulatory reporting requirements.
Support audit readiness activities, inspections, CAPA investigations, NCEP activities and other quality system processes.
Leverage data and analytics to identify trends, emerging risks and opportunities for process and product improvement.
Lead and support strategic initiatives and continuous improvement projects that enhance quality system effectiveness and operational performance.
Provide guidance, training and constructive feedback to peers while promoting knowledge sharing across the organization.
Communicate risks, deliverables and key findings effectively to leadership and cross-functional stakeholders.
Work independently and collaboratively to drive compliant, timely and effective complaint handling and regulatory reporting activities.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all applicable quality system requirements, procedures and documented processes.