Director, Regulatory Affairs

Summary

Join Natera, a global leader in cell-free DNA testing, as the Director, Regulatory Affairs. You will lead, plan, and execute regulatory registration programs worldwide, ensuring compliance and efficiency. Responsibilities include developing and implementing regulatory strategies, preparing submissions to agencies, and mentoring regulatory associates. This role requires a life science degree, at least 7 years of relevant experience in medical devices (IVD experience preferred), and strong leadership and communication skills. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, as well as free testing for employees and their families. The position is remote in the USA, with a salary range of $172,700 to $215,900.

Requirements

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent
• Minimum of 7 years of direct applicable regulatory experience in medical devices
• Working knowledge of U.S. and EU Medical Device/IVD regulatory requirements
• Demonstrated self-starter and highly motivated, energetic and enthusiastic
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving
• Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs
• Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results
• Demonstrated ability to effectively formulate and drive change
• Experienced in continuous improvement projects, project management, and product development processes
• Ability to be effective in complex projects with ambiguity and/or rapid change
• Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators
• Familiar with Design control documents; History Files, Device History Records, QC testing, Stability reports, etc
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint)

Responsibilities

• Represent the function on designated teams, conduct business interactions with customers and regulatory authorities surrounding regulatory pathway, performance claims, supporting data, and labeling (including advertising and promotional materials) in the context of submissions or registrations, and serve as the regulatory expert on the projects
• Develops and executes aggressive weighted with realistic regulatory strategies for a range of complex regulatory affairs programs with emphasis on requirements and submissions associated with IVD systems (hardware, software, reagents, etc.)
• Advocates least burdensome approaches to product clearance/approval, interpreting and providing regulatory requirements. With minimum supervision, coordinates and prepares regulatory submissions, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, and critical registrations worldwide
• Develops, monitors, and reports to senior management key performance indicators
• Mentors regulatory associates and develop for career advancement
• Leads cross-functional or cross-business teams to address process improvements, major regulatory changes or initiatives (e.g., compliance with new registration requirements, or professional development with minimum supervision)
• 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

Preferred Qualifications

• Advanced degree in life sciences (MS, PhD, etc.) and/or MBA
• RAC
• IVD experience and CDx
• PMA experience
• Minimum of 5 years managerial experience

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program
• Remote USA