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.
- 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 the U.S. and international 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.
- This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job.
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
- Must maintain a current status on Natera training requirements.
- Employee must pass post offer criminal background check.
- Bachelor’s degree in a technical discipline (biology, microbiology, or molecular microbiology) or equivalent.
- Minimum 8 years of directly related regulatory experience in the medical device and/or in vitro diagnostic device area(s) or equivalent.
- Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders.
- Previous management experience preferred.
KNOWLEDGE, SKILLS, AND ABILITIES
- Ability to think strategically, and to interpret and act upon complex or ambiguous issues, in both the immediate and broader context.
- Ability to communicate and interact effectively across all levels, disciplines, and regions.
- Ability to inspire, motivate, and build the confidence of teams to reach goals, steadfastly pushing self and others to achieve results.
- Demonstrates leadership through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.
- Demonstrates in-depth understanding of advanced technical/scientific principles that relate to a specific product line.
- Demonstrated success in supporting both growth and product support projects, including complex projects involving ambiguity and rapid change.
- Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers [e.g., 510(k), pre-Submission, IDE, PMA, EU Technical Files.
- Experienced in meeting with, making presentations to, and negotiating with regulators.
- Demonstrated success in developing strong working relationships with regulators.
- Ability to attract, recruit, mentor, and retain high-caliber professionals.
- Knowledge of regulations applying to medical devices and in vitro diagnostic devices in the U.S., EU and other jurisdictions, as appropriate.
- RAPS RAC (U.S.) preferred