Senior Regulatory Affairs Specialist

Job not on LinkedIn

🔥 28 minutes ago

🇺🇸 United States – Remote

💵 $83k - $103.7k / year

⏰ Full Time

🟠 Senior

🚔 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

• Prepare regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in domestic and international clinical markets • Develop, execute, and manage procedures and systems ensuring product development and clinical studies address regulatory requirements and business objectives • Interpret U.S. and international medical device and IVD regulatory requirements • Guide product development teams on regulatory requirements • Develop FDA and other regulatory agency submission strategies • Provide risk assessments and regulatory options • Prepare U.S. submissions including 510(k)s, PMAs and supplements, PDPs, IDEs, Pre-Submissions and supplements • Compile information for ex-U.S. product registration or licensing • Interact and negotiate with U.S. regulatory agencies • Coordinate responses to additional data and information requests from regulatory agencies • Participate in product release document development and review • Review clinical protocols and monitor clinical studies and resulting data analyses • Recommend courses of action based on clinical data and regulatory requirements • Review labels, labeling, and promotional materials for regulatory compliance • Provide regulatory opinions on premarket, export, and labeling requirements • Access PHI occasionally in paper and electronic form to perform the job

🎯 Requirements

• Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred • Minimum 5 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in regulatory affairs or equivalent • Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements • Knowledge of Good Laboratory Practices (GLP) and Quality System Regulations (QSR) • Current knowledge of European Medical Device and IVD Directive requirements and European quality system standards • Effective verbal and written communication skills • Ability to organize work • Project management experience desirable • Must complete HIPAA/PHI privacy, General Policies and Procedure Compliance, and security training within the first 30 days of hire • Must maintain current status on Natera training requirements

🏖️ 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 • 401k benefits • Commuter benefits • Employee referral program