Manager I, Product Complaint

Quality    ·      Arden Hills, MN, US       ·       Full time

Boston Scientific’s hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible: Onsite
Onsite Location(s): Arden Hills, MN, US, 55112
Additional Location(s): N/A

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

At 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: 

The Product Complaint Manager I will be responsible for managing the Post Market Surveillance staff and all related compliance activities associated with the complaint handling program at BSC per corporate, domestic and international standards.  The scope of responsibility encompasses managing the complaint processes to comply with corporate/divisional procedures and FDA regulations per CFR Part 820 and 803, and International Regulations as applicable per geographies.  He/she/they will escalate and participate in resolution of potential product deficiencies for all applicable BSC products. He/she/they will ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards. He/she/they will serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to post market surveillance activities, including risk management and complaint handling processes for all applicable products.
 

Your responsibilities include:

• Ensures all complaints are reviewed, evaluated, and investigated to determine reportability to FDA and International Regulatory Authorities
• Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals
• Plans for impact of new products, ensures training and implementation/control plans
• Maintain processes and procedures for ensuring compliance to corporate policies as well as external regulations and standards
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc)
• Initiates and implements corrective and preventive actions when warranted according to the established procedures
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures
• May interact with internal, domestic, and international auditors
• Coordinates and participates in escalation of adverse complaint trends or product issues
• Ensure appropriate training is provided to the Post Market Surveillance staff
• Manages performance and professional growth and development of the staff through the PDC program and per BSC HR policies
• Evaluates/assesses the developmental/skill needs of staff on a continuous basis to ensure appropriate competencies exist to fulfill business needs
• Recommends staffing or other necessary resources in order to achieve business goals and compliance requirements
• Oversees the accuracy, completeness, and maintenance of the complaint records as it is documented in Global Complaint Management Database
• Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports
• Contributes to the development and monitoring of area budget through regular analysis of cost and spending

Required Qualifications:

• Minimum of a Bachelor’s degree
• Minimum of 5 years of related work experience 

Preferred Qualifications:

• People management experience preferred
• Knowledge of US and international regulatory authority reporting requirements
• Experience working with Competent Authorities
• Project management experience
• Experience with CRM products
• Experience with Post Market activities
• Vendor management experience 

Requisition ID: 560836

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!

Please click here to apply.