Product Complaint Manager

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- 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: 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
  
  

Requisition ID:594791

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.

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!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.