Principal Product Complaint Analyst

Additional Location(s):US-MN-Maple Grove

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

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll 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. Youll 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 newStandard Operating Procedures and Work Instructionsto 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:

• Bachelors 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 Xcel 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

Requisition ID:626618

Minimum Salary:$102100

Maximum Salary: $194000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly) non-sales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 45 years we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular respiratory digestive oncologicalneurologicaland urological diseases and conditions. Learn more atand follow us onLinkedIn.

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 identity gender expression veteran status age mental or physical disability genetic information or any other protected class.

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 Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.