Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare regulatory submissions necessary for marketing new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets.

• Develop, implement, and oversee procedures and systems to ensure that product development and clinical studies meet regulatory requirements and align with business objectives.

• Interpret U.S. and international regulatory standards for medical devices and IVDs.

• Provide guidance to product development teams regarding regulatory obligations.

• Create submission strategies for the FDA and other regulatory agencies.

• Conduct risk assessments and present regulatory options.

• Prepare U.S. submissions including 510(k)s, PMAs and supplements, PDPs, IDEs, Pre-Submissions, and supplements.

• Compile data for international product registration or licensing.

• Engage and negotiate with U.S. regulatory authorities.

• Coordinate responses to requests for additional data and information from regulatory bodies.

• Be involved in the development and review of product release documents.

• Review clinical protocols and monitor clinical studies along with the resultant data analyses.

• Recommend actions based on clinical data and regulatory guidelines.

• Review labels, labeling, and promotional materials to ensure regulatory compliance.

• Provide regulatory insights on premarket, export, and labeling requirements.

• Occasionally access PHI in both paper and electronic formats to perform job functions.

⛳️ Requirements

• Bachelor's degree or equivalent; a degree in biological sciences, chemistry, or a related field is strongly preferred.

• Minimum of 5 years of experience in the device/diagnostic, biologic, and/or pharmaceutical industry, ideally in regulatory affairs or a comparable role.

• Up-to-date knowledge of U.S. medical device and in vitro diagnostic regulatory standards.

• Familiarity with Good Laboratory Practices (GLP) and Quality System Regulations (QSR).

• Current understanding of European Medical Device and IVD Directive requirements, along with European quality system standards.

• Strong verbal and written communication abilities.

• Capability to organize work efficiently.

• Project management experience is a plus.

• Must complete HIPAA/PHI privacy, General Policies and Procedure Compliance, and security training within the first 30 days of employment.

• Must stay current with Natera training requirements.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.

• Complimentary testing for employees and their immediate family members.

• Fertility care benefits.

• Leave for pregnancy and bonding with a newborn.

• 401k benefits.

• Commuter benefits.

• Employee referral program.