Product Complaint Manager
About The Position
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. Escalate and participate in resolution of potential product deficiencies for all applicable BSC products. Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards. Serves 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. 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.
Requirements
- Bachelor's Degree
- Minimum of 5 years of related work experience or an equivalent combination of education and work experience
Nice To Haves
- Boston Scientific experience
- Knowledge of US and international regulatory authority reporting requirements
- Experience working with Competent Authorities
- Strong management and communication skills
- Project management experience
- Effective team leadership experience
- Experience with CRM products
- Experience with Post Market activities
- Vendor management experience
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
