POSITION SUMMARY

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

PRIMARY RESPONSIBILITIES

• 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.

• 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).

• 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.