Work mode: Hybrid
Onsite Location(s): Arden Hills, MN, US, 55112
Additional Location(s): US-MN-Arden Hills; Ireland-Galway; US-MN-Maple Grove
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:
The Senior Product Complaint Manager will be responsible for planning, developing, and maintaining Post Market Surveillance compliance programs for the Cardiovascular Complaint Management Center supporting the Interventional Cardiology division. He/she will have operational accountability over understanding, documenting and communicating device performance through timely capture of field performance inputs, comprehensive investigation and analysis of relevant supporting data, consistent assessment of reporting obligations across all teams in accordance with evolving worldwide regulations, and effective, timely correspondence with customers and worldwide regulatory agencies. A key aspect of this role includes strong partnership with divisional and global Quality/Regulatory and other stakeholders to communicate overall product performance aligned with clinical and risk management product profiles. He/she/they will work closely with CMC Managers to establish and ensure compliance with applicable global regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, EU MDR, ISO 13485:2016), company and department policies and procedures.
Your responsibilities will include:
- Collaborate with divisional partners and enable PMQA to be an optimally effective partner in achieving goals and delivering products of the highest quality.
- Work closely with and collaborate with Post Market QA peers/leaders to ensure BSC-wide consistency, compliance and efficiency through shared best practices and thoughtful harmonization.
- Determine appropriate staff levels, schedules and resources.
- Recruit, coach and develop organizational talent to create a culture of effective influence and collaboration for results.
- Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
- Provide education on complaint reporting requirements to worldwide BSC employees.
- 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.
- Partner with quality writing board and risk management teams to ensure written communications are complete and align with overall product risk profile.
- Act as an effective and collaborative 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.
- Support 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.
Required Qualifications:
- Minimum of a Bachelor’s Degree
- Minimum of 10 years of related experience (complaint management, post market surveillance, quality systems)
- Minimum of 3 years of management experience
- Medical device experience
Preferred Qualifications:
- Proven leadership capabilities with a passion for developing others
- Strong communication and problem-solving skills
- High sense of urgency and commitment to execution
- Ability to make consequential decisions in a high-pressure environment, whilst bringing along stakeholders
- Demonstrated high degree of integrity, professionalism, and the ability to establish credibility internally and externally
- Promotes a high-performance, diverse and inclusive culture within a quality focused environment
- Demonstrated commitment to advancing BSC people leadership commitment through focus on coaching, listening, and developing team members
Requisition ID: 590171
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal 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.
Nearest Major Market: Minneapolis
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