Mgr, Regulatory Affairs - Remote

POSITION SUMMARY:

The Manager, Regulatory Affairs is responsible and accountable for developing and executing sound strategies for complex regulatory submissions for Natera. This position directs multiple projects of their functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registration of products with desired claims.

PRIMARY RESPONSIBILITIES:

• Represents Regulatory Affairs Function as the new product development Core Team Member.
• Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other regulatory agencies, as needed.
• Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders.
• Represents Regulatory Affairs function in interactions/negotiations with U.S. regulatory agencies.
• Represents Regulatory Affairs function in external activities benefiting Natera business interests including trade associations, professional organizations, and standards development organizations.
• Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for the U.S., EU and other jurisdictions, as appropriate.
• Identifies opportunities for continuous improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.
• Manages a staff of regulatory professionals carrying out product submission/registration activities.
• Manages the preparation and filing of premarket submissions and Technical Files.
• Manages the regulatory review of labels, labeling, and promotional materials.
• Hires, develops and retains staff to meet business needs and to create a pipeline of talented professionals for progressively challenging and responsible roles.
• Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.
• Designs and implements training on regulatory issues for staff and for …