POSITION SUMMARY:

The Director, Regulatory Affairs leads, plans, coordinates, conducts and reports on regulatory registration programs. This includes activities such as registration strategy for management of clearance/ approval/ registration/licensure documentation for submissions to regulatory agencies worldwide. Executes department and cross functional projects, identifies regulatory activities for project schedules, serves as a core team member/extended core team leader, and recommends appropriate actions on regulatory issues. In addition, provides assurance that processes and procedures related to regulatory responsibility are compliant, current and efficient. 

PRIMARY RESPONSIBILITIES:

Represents 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). 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.

QUALIFICATIONS:

B.A. or B.S. degree 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.RAC preferred.Minimum of 7 years of direct applicable regulatory experience in medical devices; IVD experience and CDx a plus.PMA experience preferred.Minimum of 5 years managerial experience preferred

KNOWLEDGE, SKILLS, AND ABILITIES:

Working knowledge of U.S. and EU Medical Device/IVD regulatory requirementsDemonstrated self-starter and highly motivated, energetic and enthusiasticDriven leadership with an emphasis on talent developmentAbility 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 resultsDemonstrated ability to effectively formulate and drive changeExperienced in continuous improvement projects, project management, and product development processes.Ability to be effective in complex projects with ambiguity and/or rapid changeExcellent 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)

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$172,700—$215,900 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents. 

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:
- BBB announcement on job scams 
- FBI Cyber Crime resource page