Regulatory Affairs Advisor

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $146.1k - $182.6k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Represent the regulatory function on designated cross-functional teams • Conduct business interactions with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, and labeling for submissions or registrations • Build and execute regulatory strategies for complex programs, especially FDA Pharma, IVDR, and IVD systems • Advocate for least burdensome product clearance and approval approaches while adhering to regulatory requirements • Coordinate and prepare regulatory submissions with minimal supervision, including EU/IVD/IVDR Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and worldwide registrations • Mentor regulatory associates and support career advancement • Deliver regulatory training across internal teams • Lead cross-functional teams addressing regulatory changes, new registration requirements, and process improvements • Contribute to individual and departmental annual goals aligned with business objectives • Review regulatory compliance of advertising, promotion, and labeling across a common product line • Identify process gaps and build data-driven solutions to improve them • Evaluate product changes for global regulatory submission impact • May lead small teams • Maintain product registrations, change assessments, post-market surveillance reports, and regulatory-authority communication records

🎯 Requirements

• Bachelor’s degree in a life science field or equivalent • Minimum of 8+ years of direct applicable regulatory experience in medical devices, laboratory-developed tests (LDTs), or pharma • Working knowledge of U.S. and EU Medical Device/IVD/IVDR, FDA Pharma, and/or laboratory-developed test regulatory requirements • Experience in continuous improvement projects, project management, and product development processes • Computer literacy, including Microsoft Word, Excel, and PowerPoint • Ability to manage multiple projects and deliver results • Ability to formulate and drive change • Excellent written and verbal communication skills, including communication across cultures and negotiation with regulators • Advanced degree in life sciences and/or MBA preferred • Regulatory Affairs Certification (RAC) preferred • Direct experience with FDA Pharma and IVDR submissions highly preferred • Experience in Organ Health or Women's Health diagnostics ideal and strongly preferred • In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) experience is a plus • PMA experience preferred

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents • Free testing for employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401(k) benefits • Commuter benefits • Employee referral program