GForce Life Sciences · 3 days ago
Regulatory Affairs Specialist
United States
Contract
Remote
Entry, Mid Level
2+ years expGForce Life Sciences is focused on regulatory compliance activities, and they are seeking a Regulatory Affairs Specialist to support regulatory submissions to FDA and other global agencies. The role involves collaborating with cross-functional teams to ensure products meet regulatory and quality requirements throughout their lifecycle.
ConsultingProject ManagementRecruiting
Hiring Manager
Fiona Bushe
Responsibilities
Support regulatory compliance by completing assessments and preparing regulatory submissions related to product clearances and approvals (e.g., FDA, Notified Bodies, and other regulatory authorities)
Assist in the preparation, review, and maintenance of regulatory documentation to ensure accuracy, completeness, and compliance with applicable regulations
Apply working knowledge of regulatory frameworks, requirements, legislation, processes, and procedures within FDA-regulated environments
Support quality system documentation and compliance activities as needed
Manage assigned regulatory activities, including planning, coordination, execution, and documentation of regulatory deliverables
Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing, Supply Chain) to support regulatory objectives and timelines
Provide regulatory guidance and act as a point of contact for regulatory-related questions within the team
Communicate project status, risks, and issues to supervisors and stakeholders on a regular basis
Work with minimal supervision, exercising independent judgment and decision-making within defined responsibilities
Handle assignments broad in scope, requiring originality, attention to detail, and problem-solving skills
Escalate unusual or complex issues to senior or supervisory staff as appropriate
Qualification
Required
Bachelor's degree (B.S. or B.A.) in Engineering, Science, or a related field
2–3 years of experience in an FDA-regulated industry
Basic to intermediate knowledge of regulatory and quality requirements
Strong organizational, writing, and project coordination skills
Preferred
RAC certification and/or a Master's degree in Regulatory Affairs
Company
GForce Life Sciences
GForce Life Sciences is a platform for career management that offers executive search, medical affairs consulting, and project management.
51-200 employees
H1B Sponsorship
GForce Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Mark Gallagher
Founder & CEO
Company data provided by crunchbase