Principal Product Complaint Analyst

Principal Product Complaint Analyst

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: Everyone at Boston Scientific works toward one goal: transforming lives by addressing the most critical challenges in the medical device industry. Patient Care is at the heart of everything we do, and ensuring quality, compliance, and positive outcomes is essential to delivering on that commitment. As a Principal Product Analyst, you will lead strategic initiatives that enhance product quality and performance across global markets. You'll collaborate with a high-performing, cross-functional team to solve complex challenges, applying data-driven insights to identify risks, improve processes, and drive decisions that make a lasting impact on healthcare worldwide. This role offers the opportunity to contribute to meaningful change as part of a team that thrives on shared success.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Understanding and ensuring compliance with US and OUS regulatory requirements for medical devices for complaint handling and regulatory reporting
• Participating in the Global Quality Community to lead large, highly impactful projects to improve post market quality across multiple divisions
• Coordinating parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to support project deliverables and timelines
• Providing and presenting succinct, clear communication to senior leadership on deliverables, timelines and milestones
• Influencing change and aligning stakeholders to make decisions with limited information
• Providing audit support
• Consistent, positive influence on the culture of the team, setting an example as a leader of high-quality work, effective communication, dealing with adversity, and solution-oriented thinking
• Utilizing data and analytics to identify areas of risk, opportunities and priorities
• Supporting and implementing new Standard Operating Procedures and Work Instructions to improve and/or standardize complaint and regulatory reporting processes
• Applying systems-thinking of a complex quality system to streamline and identify areas for improvement and identify areas of risk and provide and manage plans for improvement
• Effectively identifying and escalating risks, respectfully challenging management and status quo where appropriate, providing recommendations and working to resolve issues
• Working independently across the organization
• In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures

Required qualifications:

• Bachelor's degree, preferably in a scientific, engineering, or technical discipline
• Minimum of 5 years of medical device industry, pharmaceutical, or diagnostic device experience
• Demonstrated ability to understand, shift and contribute to changing priorities
• Competency of Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Visio, etc.)
• Working knowledge and practical implementation of FDA, ISO, MDR regulations within the medical device industry
• Demonstrated proficiency in project management

Preferred qualifications:

• Preferred experience with Post Market activities - complaints and vigilance
• Corrective Action Preventative Action (CAPA) experience
• Strong research, communication and presentation skills
• Effective written and oral communication, technical writing, and editing skills
• Ability to work independently with minimal direction or supervision
• SAS, Snowflake or similar querying/analytic software experience

Refer to ID 86737584 when applying