Principal Quality Analyst

Additional Locations:Canada-ON-Ottawa; Canada-ON-Mississauga; Canada-ON-Toronto; Canada-QC-Montreal; US-MN-Arden Hills; 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.

Are you passionate about driving quality and safety in the dynamic evolving world of healthcare technology We are seeking a Principal Quality Analyst a strategic and hands-on leader who will champion the seamless integration of medical device and radiopharmaceutical post-market surveillance programs. This role is being offered as a 2-year contract and is critical to the success of our radiopharmaceutical launch in China and offers to establish the foundation of post market surveillance for radiopharmaceuticals at Boston Scientific.

At Boston Scientific we value collaboration and synergy. This position follows ahybrid work model requiring employees to be onsite at a local Boston Scientific office at leastthree days per week.

Please note thatrelocation assistance is not availablefor this role at this time.

AdditionallyBoston Scientific does not offer sponsorship or assume sponsorship of employment visasfor this position

Your responsibilities will include:

• Lead the development and facilitation of quality systems that bridge medical device and radiopharmaceutical post-market surveillance and pharmacovigilance activities.
• Act as a central liaisonbuilding strong collaborative relationships across cross-functional teams including Regulatory Medical Safety Design Assurance Complaints teams and all key project stakeholders.
• Develop and execute comprehensive project plans for post-market surveillance and pharmacovigilance programs ensuring timely and effective delivery that meets internal and external requirements.
• Interpret and apply global regulatory requirements with a strong focus on Chinese market standards and expectations.
• Oversee the creation and implementation of risk management plans signal detection and data analysis processes to ensure ongoing product safety and compliance.
• Serve as both a doer and facilitatorrolling up your sleeves to solve problems directly while empowering others to excel.
• Represent Quality and Vigilance programs in internal and external audits inspections and stakeholder meetings.
• Other activities as required

Required qualifications:

• Bachelors or advanced degree in Engineering Life Sciences Pharmacy or related field.
• Extensive experience in medical device and pharmacovigilance program management ideally supporting launches in China or other international markets.
• Proven track record of cross-disciplinary project leadership and successful collaboration with diverse teams.
• Thorough understanding of regulatory frameworks for both medical devices and radiopharmaceuticals including global and China-specific requirements.
• Demonstrated ability to design implement and manage post-market surveillance and pharmacovigilance programs.
• Exceptional analytical organizational and communication skillsable to translate complex technical concepts for broad audiences and drive action.
• Resilient patient and action-oriented; adept at navigating ambiguity and adapting to evolving priorities.
• Fluency in English required; Mandarin proficiency is an asset.
• Ability to travel domestically and/or internationally up to 10%

Preferred qualifications:

• Proficiency in Mandarin
• Ability to quickly establish business relationships with colleagues and external partners
• Experience with implementation of computer systems to support automated processes
• Experience working with radiopharmaceuticals

Requisition ID:615724

Minimum Salary: $95600

Maximum Salary: $189800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will 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 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 salaried non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

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) isnt just business its personal. And if youre 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!