Regulatory Affairs Strategy Lead

POSITION SUMMARY

Plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services. Combines strong technical knowledge and understanding of regulatory requirements within at least one regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, or Japan to support the approval and registration of Natera’s products and services.

Represents the RA team to internal and external stakeholders through written and verbal communication within at least one product line. May represent RA in different core teams and change control initiatives. Maintains product registrations, change assessments and post-market surveillance reports and records of communication with regulatory authorities. Supports overall effectiveness of the regulatory affairs team at Natera through contributions to staff development, process improvements and understanding of current regulatory requirements.

PRIMARY RESPONSIBILITIES

Strategy & Submissions

• Develops and executes aggressive strategies weighted with realistic regulatory objectives for a range of complex regulatory affairs programs with emphasis on requirements and submissions associated with IVD systems (hardware, software, reagents, etc.).

• Coordinates and prepares regulatory submissions with minimum supervision, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical registrations worldwide.

• Advocates least burdensome approaches to product clearance/approval, interpreting and providing regulatory requirements.

• 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.

• Evaluates product changes for impact to regulatory submissions globally.

• Reviews and ensures regulatory compliance of advertising, promotion and labeling across a common product line.

Leadership & Team Support

• Represents the function on designated teams and may represent RA in different core teams and change control initiatives.

• 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).

• Mentors regulatory associates and develops for career advancement; may lead small teams.

• Delivers training on regulatory topics.

• Contributes to the setting of individual and departmental annual goals aligned with business objectives.

• Supports RA leadership in implementation of data-driven improvements in RA processes, acquisition of cross-functional leadership skills and core competencies in regulatory affairs.

• May take on “one-off” projects to support department goals and functioning.

Compliance & Administration

• Builds specialized knowledge of regulatory guidelines and requirements within one or more fields applicable to Natera.

• Maintains product registrations, change assessments, and post-market surveillance reports.

• This role will have occasional access to PHI (Protected Health Information) both in paper and electronic form and have occasional access to various technologies to access PHI.

• 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.

• Other duties as assigned.

QUALIFICATIONS

• Education: 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.

• Certification: RAC preferred.

• Experience: Minimum of 12 years of direct applicable regulatory experience in medical devices.

• Specialized Experience: IVD experience and CDx a plus; PMA experience preferred.

• Management: Minimum of 5 years managerial experience preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

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

• Professional Attributes: Demonstrated self-starter and highly motivated, energetic and enthusiastic with an emphasis on talent development.

• Problem Solving: Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, which includes analytical problem solving.

• Project Management: Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.

• Adaptability: Demonstrated ability to effectively formulate and drive change; ability to be effective in complex projects with ambiguity and/or rapid change.

• Process Improvement: Experienced in continuous improvement projects, project management, and product development processes.

• Communication: 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.

• Tools: Computer literacy (PC, Microsoft Word/Excel/PowerPoint).