Senior Product Complaint Analyst

About Boston Scientific Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.

Boston Scientific

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bostonscientific.com

10,001+ employees

Medical Equipment Manufacturing

Marlborough, MA

Public Company

1.5M LinkedIn followers

Raised $10B

• 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.
• Serve as a positive influence on team culture by modeling high-quality work, effective communication, resilience and solution-oriented thinking.
• Ensure compliance with U.S. and international regulatory requirements for medical device complaint handling and regulatory reporting.
• Review complaint communications and assess regulatory compliance, reportability and potential impact to patient safety and business operations.
• Apply clinical knowledge related to product applications to evaluate identified complaints and conduct investigations by gathering information from clinical staff, field representatives, internal stakeholders and laboratory analyses.
• Establish regulatory reportability decisions using hazard analyses, Design Failure Mode and Effects Analysis (DFMEA), reported event information, investigation findings and regulatory decision models.
• Apply appropriate coding to complaint events to support product performance records and collaborate with engineering, laboratory and other internal teams to review coding and investigation outcomes.
• Compose clear and comprehensive written communications detailing clinical observations, investigations, product analyses and corrective actions, as applicable, for physicians and other end-user customers.
• Support and lead divisional initiatives and strategic priorities.
• Review peer work products and provide constructive feedback while identifying opportunities for process improvement.
• Utilize data and analytics to identify risks, opportunities and business priorities.
• Provide clear, concise communications and presentations to leadership regarding deliverables, timelines and milestones.
• Influence change and align stakeholders to support decision-making in situations with limited information.
• Apply systems-thinking principles to identify process improvement opportunities, mitigate risk and enhance quality system effectiveness.
• Support training activities and knowledge-sharing initiatives across the organization.
• Identify and escalate risks appropriately, respectfully challenge assumptions when necessary and provide recommendations to resolve issues.
• Work independently and collaboratively across functions to achieve business objectives.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.

Required

• Bachelor’s degree in a scientific, technical or related discipline.
• Minimum of 5 years' experience in the medical device industry.
• Demonstrated ability to adapt to changing priorities and contribute effectively in a dynamic environment.
• Proficiency with Microsoft Office applications, including Word, Excel and PowerPoint.
• Working knowledge and practical application of FDA, ISO and other applicable medical device regulations.

Preferred

• Experience supporting corrective and preventive action (CAPA) activities.
• Experience handling complaints for neuromodulation or implantable medical device products.
• Strong research, communication and presentation skills.
• Strong technical writing, editing and documentation skills.
• Ability to work independently with minimal direction or supervision.
• Experience utilizing data analytics to support quality, compliance or business decision-making.
• Proven ability to influence cross-functional stakeholders and drive process improvements.
• Experience presenting recommendations and project updates to leadership audiences.

• Health insurance
• Annual bonus target
• Long-term incentives