Regulatory Specialist II -

Regulatory Specialist II (Remote – Pacific Time Zone)

Position Overview

A medical‑device organization is seeking a Regulatory Specialist II to support regulatory submissions, documentation management, and ongoing compliance activities. This is a remote role that must align with West Coast business hours (8:00 AM–5:00 PM or 9:00 AM–6:00 PM PT). The position begins with structured training, followed by a primary focus on archiving regulatory submissions to reduce backlog. After this phase, responsibilities will expand into broader regulatory support functions.

This role is part of a 12‑person regulatory team, with day‑to‑day collaboration alongside a smaller group of 2–3 specialists.

Note: Candidates with a medical writing background will not be considered.

Assignment Details
• 12‑month contract, potential extension based on business needs
• Must be authorized to work in the U.S. (no sponsorship now or in the future)
• Job Purpose

Provide Regulatory Affairs support for submissions, documentation, and compliance activities throughout the product development lifecycle.

Key Responsibilities

Regulatory Strategy & Communication
• Serve as a company representative in communications with regulatory reviewers, including pre‑submission strategy, regulatory pathways, testing expectations, and follow‑up questions.
• Support development and execution of regulatory strategies for new and modified medical devices.

Product Development Support
• Act as a core team member on product development teams, providing regulatory guidance throughout the lifecycle.
• Review and approve product and manufacturing changes for regulatory compliance.

Submission & Documentation Management
• Prepare and submit regulatory applications and maintain internal regulatory files.
• Review labeling, promotional materials, and advertising for compliance with submissions and applicable regulations.
• Manage regulatory archiving systems—a primary responsibility during the initial phase of the assignment.

Quality & Compliance
• Maintain strict adherence to the Quality Policy and all documented procedures.
• Promote a culture of patient safety and product quality in all activities.

Required Qualifications
• BS degree with 2–4 years of relevant experience, or MS degree with 0–2 years
• Demonstrated experience in Regulatory Affairs
• Proficiency with Microsoft Office
• Experience using regulatory management systems for submission archiving
• Strong written and verbal communication skills
• Ability to work independently with minimal supervision
• Collaborative, team‑oriented mindset
• Professional remote work environment with reliable internet
• Medical writers will not be considered

Preferred Qualifications
• Master’s degree in Regulatory Affairs
• Experience with Windchill or similar systems

Additional Notes
• Team size: ~12, with close collaboration among 2–3 peers