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For your reference, we have included the original job posting below.
Senior Regulatory Affairs Specialist
Job Number:
22417320
Company Name:
Boston Scientific
Job Location:
Marlborough, MA US
Job Category:
Healthcare & Medical
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist Requisition ID 31828 Full/Part Time x Location
Marlborough MA
Description Senior Regulatory Affairs Specialist - Endoscopy - Marlborough, MA 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. Key Responsibilities: • Prepares submissions to obtain and maintain global regulatory approvals for clinical research and commercial distribution of Endoscopy products. • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. • Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review. • Develops and implements regulatory strategies for new and modified products. • Provides regulatory guidance and direction as a core member on manufacturing and development teams, throughout the product development cycle, and identifies/coordinates cross functional deliverables for submissions. • Reviews and approves device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes. • Reviews and approves product and manufacturing changes for compliance with applicable regulations. • Develops and implements departmental and divisional policies and procedures. Supports highly technical or major business segment product lines, special projects or strategic initiatives. Qualifications: • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline. • Professional certification(s) preferred. • 5-8 years Regulatory Affairs medical industry experience. Medical Device experience required. International experience a plus. • Demonstrated success in management of regulatory submissions activities. Must have experience with 510k submissions. • Thorough understanding of global regulations. • Strong technical knowledge of medical products. • Strong technical understanding of relevant procedures, practices, and associated medical terminology. • Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements. • Thorough knowledge of product development process and design control. • Excellent research and analytical skills. • Ability to manage multiple projects. • Excellent written and oral communication, technical writing and editing skills. • Strong leadership, interpersonal and influencing skills. • Proficiency with Microsoft Office.
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