Principal Specialist, Corporate Clinical Quality Assurance

Principal Specialist, Corporate Clinical Quality Assurance Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): N/A 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. About the role: The Corporate Clinical Quality Assurance (CQA) Principal Specialist will manage Corporate CQA activities in alignment with the strategies and goals set by Quality and Clinical leadership. This role plays a key part in ensuring the effectiveness of clinical quality systems and compliance with global regulatory standards through process improvement, oversight, and strategic collaboration. 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. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time. Your responsibilities will include: Collaborate with Quality and Clinical leadership to support the Clinical Trial Quality System subprocess, including continuous process improvements, maintenance of procedures in compliance with regulatory requirements, and mitigation of compliance risks. Partner with Global Clinical Operations to ensure ongoing compliance of clinical research activities and to drive operational efficiency through process improvement initiatives and clinical systems. Lead quality escalation discussions with global, cross-functional partners; drive and oversee non-conformances (NCEPs) and corrective/preventive actions (CAPAs); own CAPAs as needed. Serve as a consultant on the interpretation of regulations and their application to clinical trial processes, translating them into practical, compliant quality system requirements. Identify key areas of regulatory risk and propose resolutions to improve compliance with applicable regulations, BSC policies, and procedures. Partner with divisional and regional Clinical Quality teams to gather data for management review presentations. Support analysis of clinical metrics to identify trends and opportunities for improvement. Support internal and external audits of Boston Scientific, as needed. Review standard operating procedures (SOPs) to ensure compliance with regulations and BSC policies; lead SOP development when appropriate. Lead project activities under the direction of Quality Management, including the development of project plans outlining work streams, timelines, roles, and resources. Communicate project status, risks, and resolutions to management for key initiatives. Foster cross-functional relationships to enable knowledge sharing, best practice adoption, and continuous improvement across the Clinical organization. Promote a diverse and inclusive workplace that empowers all individuals to reach their full potential. Qualifications: Required qualifications: Bachelor’s degree in Life Sciences, Engineering, or a related field Minimum of 8 years' experience in Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs Medical device industry experience required Extensive knowledge of FDA, ISO, EU MDR, and medical device quality requirements governing human subject research Excellent organizational, execution, and communication skills Requisition ID: 623315 Minimum Salary: $106800 Maximum Salary: $202900 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 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. 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! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 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 Company’s 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. 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