Sr Manager Regulatory Affairs

• Develop and maintain relationships with Senior Management and other key stakeholders to support design and execution of the company’s regulatory strategy and priorities.
• Engage in problem-solving with cross-functional groups to influence company strategies and decisions as they relate to Regulatory activities.
• Make independent decisions for routine regulatory strategies and tasks; for more complex issues consult with regulatory senior management.
• Coach, mentor, and train a team of Regulatory Affairs Specialists in regulatory requirements, project team support, and creative approaches to new devices and device change assessments as described in the following areas.
• Prepare regulatory filings such as 510(k), IDE, PMA, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments including associated deliverables, and timelines.
• Represent Regulatory discipline in Project Teams to ensure timelines and appropriate resource allocations are factored into deliverables.
• Participate in the development of global regulatory strategies for various projects.
• In consultation with Regulatory leadership, prepare cross-functional teams and senior management for regulatory agency discussions and negotiations; may lead the interactions in teleconferences and face-to-face meetings.
• Key contact for FDA and Notified Body submissions and onsite audit management.
• Based on Regulatory knowledge and experience, devise creative approaches to compliantly solve difficult challenges.
• Communicate information on device intended use and supporting data to help ensure company compliance of advertising and promotional materials.
• Establish operational objectives, policies, procedures and work plans to improve department and company-wide activities.
• Review and approve applicable design and manufacturing changes, Document Change Order requests, CAPAs, NCRs, etc.
• Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols.
• Develop and maintain relationships with cross-functional stakeholders.
• Manage coordination of international product registrations and licensing documentation.
• Partner with Clinical Affairs to provide input to clinical data requirements for regulatory submissions and prepare critical data for physicians.

• Bachelor’s degree in a related field and a minimum of 8 years of experience in healthcare-related or medical device industries; or a combination of education/training and experience
• Prior people management experience strongly preferred.
• Experience with IDEs, PMAs and 510(k) filings, EU Medical Device Regulations, and other international submissions.
• An advanced degree is desirable; experience with intravascular technologies is a plus.
• Excellent written and oral communication skills; technical writing capabilities are a must.
• A proven decision maker, hands-on and action-oriented style must be evident.
• RAC certification a plus.
• Proven ability to manage a team of regulatory professionals and prioritize and execute on multiple projects independently.

Last updated on Dec 17, 2024