Product Complaint Analyst II

Additional Locations: Costa Rica-Heredia

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.

About the role: 

The Product Analyst II analyzes Customer Complaints to determine which are regulatory reportable and coordinates activities with internal, field and end-use Customers. He/she/they is responsible for adherence to Good Documentation Practices (GDPs) and Complaint Handling per the Code of Federal Register (CFR) and all other international governmental regulations. He/she/they will communicate event investigation results via regulatory reports and written communications, as appropriate.

Your responsibilities will include:

• Apply policies and procedures to comply with FDA and OUS regulations
• Evaluate incoming information for Medical Device Reporting and Vigilance reporting eligibility
• Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (MDVs)
• Interface and collaborate with internal and external contacts to collect complaint information efficiently
• Complete continuous compliance training in a timely manner
• Maintain awareness of new products, government regulations, and requirements
• Perform other duties as assigned

Required qualifications:

• Bachelor's degree in STEM, Health Care or related field
• Minimum of 2 years of experience in a health care, clinical, technical, scientific, and/or related field
• Advanced english

Preferred qualifications: 

• Experience with TrackWise-based complaint handling system
• Experience with submissions of MDRs and MDVs
• Experience evaluating and investigation patient complication/death events
• Medical device industry experience
• Post market/Quality
• Attention to detail
• Critical thinking skills
• Excellent written and verbal communication skills
• self-motivated, goal-driven and results-oriented team player

Requisition ID: 599642

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.