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