Additional Locations: (n/a)
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About the role:
This position will lead the impact assessment of global regulatory changes on the Clinical Quality System and drive the implementation of solutions to ensure compliance through effective, efficient and sustainable processes. Manage and drive select Corporate Clinical Quality Assurance activities in line with strategies and goals set by Quality management.
Key responsibilities include:
• Provide subject matter expertise on worldwide regulatory requirements governing Human Subject Research; advises management on the possible ramifications of regulatory changes, prepares gap analysis, and partners with Clinical organization to mitigate risks/implement required changes and ensure QS compliance
• Acts as a consultant relative to the interpretation of regulations and their impact on clinical trial processes, procedures and implementation.
• Champion and/or provide SME support to MedTech advocacy initiatives
• Partner with Quality and Clinical senior management to align on priorities for maintaining the Product Approval – clinical trial quality system subprocesses, including process improvements, maintenance of procedures to regulatory requirements, and addressing non-compliance risks.
• Reviews SOPs to assure compliance with regulations and BSC policies and procedures. Leads development of BSC policies and procedures, as needed.
• Identify areas of regulatory risk and suggest potential resolutions.
• Identify ways to improve compliance with regulations and BSC policies and procedures.
• Directs the activities of projects, as needed. Develop project plans outlining work plans, timelines, roles and resources.
• Communicate status, risks, and resolutions to management on key initiatives.
• Creates relationships and global networks across the enterprise that enable sharing of knowledge, best practices, and solutions that can be leveraged for clinical.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices.
What we’re looking for in you:
• Bachelor’s degree in Life Sciences, Engineering, or related field
• 8+ years of Regulatory Affairs, Clinical Quality Systems or Clinical Trials Operations/Project Management experience
• Medical device industry experience required
• Extensive knowledge of GCP and international regulations/standards/guidance governing human subject research (EU MDR, ISO 14155, ICH GCP, etc.)
• Excellent organization, execution and communication skills required
• Ability to communicate with all levels of the organization
• Experience in developing and maintaining written procedures
• Travel up to 25% can be expected
** Please note: This position may be filled at the Principal or Fellow level depending on the final candidate’s experience and expertise.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 450682