Sr Manager, Product Complaint

Additional Locations:  N/A

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes onsite. You will have the opportunity to discuss details in the interview. 

About the role:

Plan, develop and maintain Post Market Surveillance compliance programs, policies, and processes.  Create and champion improvement in the application of Quality System.   Interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. May serve as liaison between the company and various governmental agencies. Work directly with operating entities to ensure that Post Market Surveillance product complaint management processes are performed as required. May manage work done offsite and through 3rd party vendors.  Work closely with CISs and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.

You're Responsibilities include:

• Recruit, coach and develop organizational talent.
• Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
• Develop and maintain Post Market Compliance programs, policies, and processes.
• Develop and facilitate training and training support for the Post Market Surveillance organization.
• Work cross-functionally to identify and resolve issues.
• Determine appropriate staff levels, schedules and resources.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Drive projects of major magnitude and scope.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Provide solutions to a variety of technical and systematic problems of moderate to major scope and complexity.

What We’re Looking For:

• Bachelor's degree in Engineering
• English Level desired: B2+
• Experience: 10+ years
• Or an equivalent combination of education and experience.

Requisition ID: 606171

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!

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.