Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Pr. Regulatory Affairs Specialist
Description
General Summary:
The Principal Regulatory Affairs Specialist will prepare a full range of regulatory strategies and the corresponding documents for submission, review and approval by FDA in support of Boston Scientific's Electrophysiology Devices.
SPECIFIC DUTIES AND RESPONSIBILITIES:
• Fully support the Quality Policy by building quality into all aspects of the work and by maintaining compliance to all quality requirements
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
• Filings include PMA, 510k, IDE, and letter-to-file.
• Schedules, plans and conducts meetings with Office of Device Evaluation.
• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
• Plans and coordinates implementation of validation strategies and schedules with Engineering, Clinical Research and Quality Assurance personnel, for multiple project teams.
• Develops and implements departmental and divisional policies and procedures.
• Supports the creation of written company standards and policies to support ISO 9000, including the creation of technical files, design dossiers and CE Marking.
• Reviews and approves document change orders.
• Assists with regulatory inspections by FDA investigators or Notified Body auditors.
• Shares responsibility and authority for maintaining GMP and ISO compliance throughout the organization.
• Develops and implements regulatory strategies for new and modified products.
• Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
• Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Supports highly technical or major business segment product lines, special projects or strategic initiatives.
• Other duties as assigned.
Position Qualifications
• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline. Professional certification(s) preferred. 8 plus years Regulatory Affairs medical industry experience, preferably with cardiovascular disposable devices.
