Careers at Research Lifecycle Solutions
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Part Time Regulatory Associate
Job Title: Part-Time Regulatory Associate
Company: Research Lifecycle Solutions
Location: Remote
Hours: 20 hours/week
Job Type: Part-Time
About Us:
Research Lifecycle Solutions is a global firm that partners with medtech and biotech to achieve successful market launch and commercialization. We help companies to streamline regulatory, clinical, and various business management research operations. We’re growing and looking for a regulatory pro to support our expanding medical device client base.
Position Overview:
We’re seeking an experienced Regulatory Associate to provide part-time support on medical device projects. The ideal candidate has a strong background in U.S. medical device regulations, with hands-on experience preparing and submitting documents to the FDA. This is a remote position with flexible scheduling.
Responsibilities:
Prepare, review, and submit regulatory filings for medical devices (e.g., 510(k), IDE, De Novo, PMA)
Interpret FDA regulations and provide guidance to clients and internal teams
Track submission timelines and maintain regulatory documentation
Support regulatory strategy development for product development and commercialization
Coordinate with leadership (C-suite) and cross-functional teams including clinical, quality, and R&D
Review and summarize clinical evidence to support regulatory strategies (highly preferred)
Requirements:
Bachelor’s degree in a relevant field (science, engineering, business or regulatory affairs)
Minimum of 5 years of experience in medical device regulatory affairs role
Proven experience with FDA submissions
Strong understanding of U.S. medical device regulations (21 CFR, guidance documents, etc.)
Excellent communication and documentation skills
Ability to work independently and manage priorities across multiple projects
Experience with clinical evidence for regulatory submissions is a plus
What We Offer:
Flexible remote work
Collaborative team and supportive culture
Opportunity to work across a range of medical device technologies
Opportunity to grow and expand to biotech knowledge