Boston Scientific Product Complaint Manager 

United States, Minnesota, Arden Hills 

701427628

You can also pull from the Purpose Statement from the Job Description database.
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.

Your responsibilities will 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:

• Bachelor's Degree
• Minimum of 5 years of related work experience or an equivalent combination of education and work experience

Preferred qualifications:

• 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
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.