Boston Scientific · 6 hours ago
Principal Specialist, Corporate Clinical Quality Assurance
Marlborough, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$107K/yr - $203K/yr
8+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. The Corporate Clinical Quality Assurance Principal Specialist will manage CQA activities to ensure compliance with global regulatory standards and improve clinical quality systems through strategic collaboration and process improvements.
Health CareMedicalMedical Device
No H1B
Responsibilities
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
Minimal travel required
Qualification
Required
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
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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