Job Description

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, 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.
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 a hybrid work model, requiring employees to be onsite at a local Boston Scientific office at least three days per week.
Please note that relocation assistance is not available for this role at this time.
Additionally, Boston Scientific does not offer sponsorship or assume sponsorship of employment visas for 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 liaison--building 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 facilitator--rolling 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:

• Bachelor's 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 skills--able 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) 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!

Skills Required