Product Complaint Manager I Job

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Purpose and Passion • Comprehensive 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.


Product Complaint Manager I


About this role:

Responsible for the managing the Post Market Surveillance staff and all related compliance activities associated with complaint handling in both the Endoscopy and Urology/Pelvic Health divisions.

The scope of responsibility encompasses managing the complaint processes to comply with corporate procedures and applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, and ISO 13485:2003).  Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards.  


 Your responsibilities include:

  • Ensures efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities.
  • Ensure departmental adherence to, and proper interpretation and complaint handling per the Code of Federal Register (CFR) and International Competent Authority regulations.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc.).
  • Monitors daily work operations as well as overall quality of processing, decision making, and reporting.
  • Works with the Manager II to identify key department objectives and metrics; implements strategies to meet them.
  • Leads development of operational policies and procedures within the Complaint Management Center. Works cross functionally to ensure optimal processes exist to support upstream and downstream customer needs.
  • Leads process and quality improvement initiatives.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Builds strategic partnerships to further departmental and organizational objectives.


What we’re looking for in you:

  • Bachelor's degree plus 4+ years of related work experience or an equivalent combination of education and work experience.
  • Experience in medical device products and/or Post Market activities
  • Strong management and communication skills
  • Solid understanding of FDA 820/803 and ISO 13485 regulations
  • Strong analytical and problem solving skills, including the ability to identify and implement novel solutions to meet business needs
  • Ability to respond effectively and efficiently to changing demands
  • Demonstrated ability to motivate, lead, make decisions, and work in cross-functional teams
  • Strong organizational skills; can orchestrate multiple activities at once to accomplish goals as well as use resources effectively and efficiently


About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.


Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran


Requisition ID: 417893


Boston Scientific
Full time
Marlborough, Massachusetts 01752, US