Asbe Technologies, LLC is a regulatory affairs consulting firm supporting medical device, biotechnology, pharmaceutical, and life sciences companies with global regulatory strategy and compliance. The company specializes in U.S. FDA, EU MDR, and international regulatory requirements, providing practical regulatory solutions for startups and established organizations throughout the product lifecycle.
Services include regulatory strategy, FDA submissions (510(k), IDE, PMA, Q-Sub/Pre-Sub), EU MDR Technical Documentation, Health Canada submissions, labeling and change management, regulatory assessments, quality system support, and market access strategies across global markets.
Asbe Technologies partners closely with clients to develop efficient, practical regulatory solutions while maintaining compliance with applicable regulatory requirements.
Role Description
We are looking for a motivated Regulatory Affairs Associate / Business Operations Coordinator to join our growing consulting practice. This is a flexible, remote contract opportunity with hours based on active client projects. As our client base expands, there will be opportunities for increased responsibility and long-term collaboration.
This role combines regulatory support with business operations and project coordination. The ideal candidate enjoys working in a fast-paced consulting environment and is comfortable supporting multiple clients and projects simultaneously.
Responsibilities may include:
• Assisting with preparation and organization of regulatory documentation for FDA, EU MDR, and international submissions
• Conducting regulatory research using FDA guidance documents, standards, and global regulations
• Preparing first drafts of regulatory documents, reports, and client deliverables
• Coordinating project timelines and tracking deliverables
• Organizing project files and maintaining document control
• Scheduling client meetings and preparing agendas
• Attending client meetings, documenting meeting minutes, and tracking action items
• Preparing status reports and supporting project management activities
• Assisting with proposal preparation and business development initiatives
• Supporting internal process improvements as the consulting practice grows
Qualifications
• Bachelor’s degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Regulatory Affairs, or a related field preferred
• Experience in Regulatory Affairs, Quality Assurance, Medical Devices, Pharmaceuticals, Biotechnology, or Healthcare
• Familiarity with FDA medical device regulations and/or EU MDR
• Excellent written and verbal English communication skills
• Strong organizational skills with exceptional attention to detail
• Ability to manage multiple priorities in a remote consulting environment
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)
• Experience with project management software is a plus
• Ability to work independently while collaborating effectively with clients and cross-functional teams
The ideal candidate is someone who:
• Has a strong interest in Regulatory Affairs and medical devices
• Enjoys both technical work and client interaction
• Is proactive, organized, and eager to learn
• Can professionally represent the company during client meetings
• Has excellent documentation and communication skills
• Wants to grow alongside a small but expanding consulting business
Compensation
• Remote
• Flexible hours
• Contract/Freelance
• Project-based workload
• Opportunity for long-term collaboration as the business grows
• Compensation based on experience, location, and project scope
• $35-$65/hr
Pay: $35.00 - $65.00 per hour
Benefits:
• Flexible schedule
Education:
• Bachelor's (Required)
Experience:
• Regulatory Affairs : 1 year (Required)
Security clearance:
• Confidential (Required)
Work Location: Remote