POSITION SUMMARY:

The Director, Regulatory Affairs at Natera contributes to the success of Natera's in vitro diagnostics in the fields of women's health, oncology and organ health worldwide. This individual is accountable for establishing and executing sound regulatory strategy and drive adoption of regulatory requirements across multiple project teams. This individual will lead a team of regulatory professionals to author regulatory submissions required to market new or modified in vitro diagnostic devices / Laboratory Developed Tests in both domestic and international clinical markets.  This individual will execute department and cross functional projects, identify regulatory activities for project schedules, serve as a core team member/extended core team leader, and recommend appropriate actions on regulatory issues. In addition, the Director, Regulatory Affairs ensures that processes and procedures related to regulatory responsibility are compliant, current and efficient.

PRIMARY RESPONSIBILITIES:

• Understands and interprets U.S. and international in vitro diagnostic device (IVD) regulatory requirements.

• Understand and interprets requirements of CAP / CLIA / NYS DoH

• Provides guidance on requirements to product development.

• Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests. 

• Reviews labeling and promotional materials for compliance with applicable regulations and policies.

• Authors full components of complex regulatory submissions for new and modified in vitro diagnostic devices / Laboratory Developed Tests

• Expands regulatory status of existing products through registrations and compiling required information

• Reviews and ensures regulatory compliance of advertising, promotion and labeling across different product lines

• Leads and collaborates with multiple teams to help ensure product development processes, including clinical studies, meet regulatory requirements and support needs of business

• Leads in domestic and international regulatory requirements across laboratory, software, manufacturing and clinical components of regulatory approvals

• Communicates and supports implementation of regulatory requirements across all levels, disciplines, and regions.

• Mentors and develops professional contributions and career opportunities for team members

• Conducts 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 serves as the regulatory expert on the projects.

• 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) and PMA premarket authorizations, post-market notifications, medical device reporting, NYS DoH applications, and critical registrations worldwide.

• Develops, monitors, and reports to senior management key performance indicators. 

• Mentors regulatory associates and develops 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). 

• Exercises independent judgment and discretion within a broadly defined range of policies and practices.  This includes analytical problem solving.

• Demonstrates ability to juggle multiple tasks and to prioritize and schedule work to meet business needs. 

• 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) 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.

QUALIFICATIONS:

• Bachelors, Masters or PhD in in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred. 

• 8+ years of work experience in medical device, in vitro diagnostic devices or a relevant combination of skills, education, and experience; direct experience with 510(k) or PMA applications for in vitro diagnostics or process of such for next generation sequencing applications or DNA analysis relevant to Natera and 6-8 years leading small to mid-sized teams.

• RAC preferred.

• PMA experience preferred.

• IVDR experience preferred.

• Global clinical trial regulations knowledge preferred.

• Minimum of 5 years managerial experience preferred

KNOWLEDGE, SKILLS, AND ABILITIES:

• Working knowledge of U.S. and EU Medical Device/IVD regulatory requirements

• Working knowledge of next generation sequencing

• Demonstrated self-starter and highly motivated, energetic and enthusiastic

• Driven leadership with an emphasis on talent development

• 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)

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Travel – Approximately 10% of work time will be spent traveling but flexibility required to meet changing business needs.

• Duties are typically performed in an office setting. 

• This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. Duties may require working outside normal working hours (evenings and weekends) at times.