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