Regulatory Affairs Advisor (San Carlos, CA OR Remote, USA)
- San Carlos, CA
The Regulatory Affairs Advisor is an individual contributor that leads, plans, coordinates, conducts, and reports on regulatory projects and 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. Provides regulatory advice, analysis and impact assessments on legislation, industry guidance, and other initiatives. Perform a wide range of analysis to support the company's view of regulatory developments.
Location: San Carlos, CA or Remote, USA
- Represents the function on designated teams.
- 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.
- Serves as the regulatory expert on projects.
- May facilitate communications and meetings with regulatory authorities.
- 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.
- Mentors regulatory associates and develops for career advancement.
- May take on "one-off" projects to support department goals and functioning.
- Delivers training on regulatory topics.
- 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.
- Employee must pass post-offer criminal background check.
- Bachelor'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 12 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 requirements.
- Demonstrated self-starter and highly motivated, energetic and enthusiastic.
- Emphasis on talent development.
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, which 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.
- Computer literacy (PC, Microsoft Word/Excel/PowerPoint).
PHYSICAL DEMANDS & WORK ENVIRONMENT
- Travel - Approximately 5% of work time will be spent traveling with 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.
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
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. Healthy catered lunches, Premium snacks and beverages, Onsite gym with cardio and weight-training equipment, Game room with satellite TV, Onsite dry cleaning and alteration service with pick-up and delivery, Employee-organized sport leagues, Happy hours and BBQs, 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.
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