[Hiring] Regulatory Affairs Advisor @Natera

Role Description

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.

Qualifications

• 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.

Requirements

• Working knowledge of U.S. and EU Medical Device/IVD regulatory requirements.
• Demonstrated self-starter and highly motivated, energetic and enthusiastic with an 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 organizational, planning, and program management skills, including action oriented, focused urgency and driving for results.
• Demonstrated ability to effectively formulate and drive change; ability to be effective in complex projects with ambiguity and/or rapid change.
• Experienced in continuous improvement projects, project management, and product development processes.
• 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).

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for Natera employees and their immediate families in addition to fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Generous employee referral program.