Product Complaint Analyst II

Additional Locations: N/A

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

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role: The Product Complaint Analyst II provides technical reporting and analytical support expertise in reviewing of product quality complaints serving as primary contact. Monitors complaint information and provides suggestions to appropriate company authorities as to where improvement opportunities exist based upon patterns and related analyses. Provides technical expertise to optimize complaint analysis strategies and systems. Monitors systems and data to facilitate the appropriate and timely handling of all product complaints per the companys compliant handling procedure. Ensures compliance with applicable regulations company policies and procedures.

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.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Review complaint communications and assess for regulatory compliance reportability and potential impact to patient safety and business operations.
• Apply clinical knowledge as related to product application to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff field representatives internal employees and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Author Medical Device Reports (MDRs) MedWatch Vigilance and other regulatory reports ensuring timely transmission to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering laboratory and other internal staff.

Required qualifications:

• Bachelors degree
• Minimum of 1 year of related experience

Preferred qualifications:

• Previous Complaint Handling experience
• Knowledge of medical devices and associated regulations
• Post market surveillance experience or knowledge.

Requisition ID:609722

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) isnt just business its personal. And if youre 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!