Product Complaint Analyst - II
American Free Zone, San Franci, CR
Additional Locations: Costa Rica-Heredia
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About the role:
The Complaint Analyst evaluates customer complaints to determine regulatory reportability and coordinates complaint-related activities with internal teams, field representatives, and end users. This role supports compliance with Good Manufacturing Practices (GMPs), the Code of Federal Regulations (CFR), and other applicable requirements for complaint handling. The position conducts and documents complaint investigations, prepares regulatory reports, and communicates investigation outcomes as appropriate. Through these activities, the role supports patient safety, product quality, and timely regulatory compliance.
Work Mode:
This role follows a hybrid work model. Employees are expected to work from the Global Hub, American Free Zone, Costa Rica office at least three days per week, with the remaining days worked remotely.
Your responsibilities will include:
-
Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations.
-
Participate in the development and modification of regulatory decision models as products and therapies evolve.
-
Investigate complaints by gathering and evaluating information from clinical staff, field representatives, internal employees, and laboratory analyses.
-
Compile and document investigation findings and regulatory reportability decisions.
-
Prepare Medical Device Reports (MDRs), MedWatch reports, Vigilance reports, and other regulatory submissions.
-
Apply event codes and collaborate with Engineering, Laboratory, and Quality teams to support investigations.
-
Draft customer communications regarding investigation findings and corrective actions.
-
Support returned device processing, engineering evaluations, training activities, and audit readiness.
-
Perform additional duties as assigned.
Required qualifications:
-
Bachelor's degree in Engineering, Science, Biomedical Engineering, Biotechnology, or a related field.
-
Advanced English proficiency.
-
Up to 2 years of professional experience.
Requisition ID: 635243
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.
Job Segment:
Biomedical Engineering, Compliance, Law, Engineer, Social Media, Engineering, Legal, Marketing