Senior Product Complaint Analyst

Boston Scientific; Arden Hills (MN); Hybrid; USD 72,000 - 136,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Senior Product Complaint Analyst to drive compliant, timely handling of customer complaints and regulatory reporting across global markets. You will evaluate investigations, prepare MDRs/MDVs, and support post-market surveillance within the Cardiac Diagnostics team.

The role requires a minimum of 5 years in medical device complaint handling or related regulatory functions, with a strong emphasis on GMP, ISO and FDA regulations.

Qualifications

• Associate’s degree in a scientific, technical, or related field, plus relevant industry experience; or a Bachelor’s degree in a scientific, technical, or related field.
• 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 (Word, Excel, PowerPoint).
• Working knowledge of FDA, ISO and other applicable medical device regulations.

Responsibilities

• 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.

Skills

Analytical skills

Communication skills

Regulatory knowledge

Problem solving

Education

Associate's degree in scientific/technical field

Bachelor's degree in scientific/technical field

Tools

Microsoft Office (Word, Excel, PowerPoint)

Job description

Additional Location(s): US-MN-Arden Hills; US-MN-Mankato/Rochester; US-TX-HoustonDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.About the role: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.Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Relocation assistance is not available for this position at this time.Your responsibilities will include: 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.Qualifications:Required qualifications: Associate’s degree in a scientific, technical, or related field, plus relevant industry experience; or a Bachelor’s degree in a scientific, technical, or related field. 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.Preferred qualifications: 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.Requisition ID: 633627Minimum Salary: $ 71500Maximum Salary: $ 135800The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.