Job Number:
HC-03980
Date Posted:
March 27, 2026
Position Title:
Regulatory Affairs Advisor
Party:
N/A
Office Code:
Office/Company:
Natera
Reports To:
Location:
Remote
Contact:
Salary:
$146,100 – $182,600 USD
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
Regulatory Affairs Advisor plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services.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.).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.
Responsibilities:
• 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.
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.
• Specialized Experience: IVD experience and CDx a plus; PMA experience preferred.
Instructions:
Email to apply
Other:
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.
