Senior Regulatory Affairs Specialist

Summary

Join Natera as a Sr. Regulatory Affairs Specialist and contribute to the preparation of regulatory submissions for medical and in vitro diagnostic devices in domestic and international markets. You will develop and manage procedures to ensure regulatory compliance throughout the product development process, including clinical studies. This role involves interpreting U.S. and international regulatory requirements, providing guidance to product development teams, and developing strategies for submissions to regulatory agencies. You will also prepare regulatory submissions, coordinate data requests, participate in document reviews, and monitor clinical studies. The position requires occasional access to PHI and necessitates completion of HIPAA/PHI privacy training. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, free testing for employees and their families, fertility care benefits, and more.

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 the area of regulatory affairs or equivalent
• Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards
• Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization

Responsibilities

• Understands and interprets U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements
• Provides guidance on requirements to product development teams
• Develops strategies for submissions to FDA and other regulatory agencies
• Provides risk assessments and regulatory options
• Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements
• Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S
• Interacts and negotiates with U.S. regulatory agencies
• Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests
• Participates in the development and review of product release documents
• Reviews clinical protocols to assure collection of appropriate data for regulatory submissions
• Periodically monitors status of clinical studies and reviews analysis of resultant clinical study data
• Based on these data and considering the regulatory requirements, recommends appropriate courses of action
• Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies
• Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirements
• This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job
• 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

Preferred Qualifications

Ability to organize work, project management experience desirable

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more
• We also offer a generous employee referral program!