Regulatory and Product Compliance Specialist
Aura
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $85,000 - $115,000 per year
Job Level
Mid-LevelSenior
About the role
- Manage all aspects of IRB, including ongoing reviews/amendments for existing protocols and preparation and submission of new protocols. Maintain correspondence with IRB in a timely fashion and communicate clearly with the rest of the study team.
- Develop and implement processes to monitor compliance with approved protocols; and to maintain and improve data quality and integrity
- Conduct internal audits to identify areas of non-compliance and develop corrective action plans. Create or update standard operating procedures (SOPs) to reflect regulatory changes.
- Develop and implement SOPs to govern the MLR process and ensure compliance across the organization; to ensure all claims and information are compliant with regulations
- Serve as a subject matter expert on regulatory requirements, providing strategic guidance to senior management and product development teams on regulatory requirements, helping to navigate the path from research and development to market entry.
Requirements
- Bachelor’s degree in a relevant field (e.g., Psychology, Life Sciences, Chemistry, Biology, Pharmacy, Biomedical Engineering); Master’s degree in Regulatory Affairs, Public Health, or a related scientific discipline preferred.
- 4–6 years of professional experience in a regulatory or related role within an academic or industry setting.
- Strong understanding of regulatory frameworks and guidance for health-related products and clinical research (e.g., FDA, FTC Health Products Compliance Guidance).
- Experience with product lifecycle management and quality systems (e.g., QMS).
- Exceptional attention to detail, organization, and documentation skills; proficiency with document management systems.
- Excellent written and verbal communication skills, with the ability to interpret and apply complex regulations.
- Demonstrated analytical and problem-solving capabilities; able to effectively escalate issues and resolve conflicts.
- Self-motivated and proactive, with the ability to work independently and collaboratively.
- Curious, adaptable, and innovative — with an interest in the intersection of technology use and well-being in children and adolescents.
- Willingness to travel 2–4 weeks per year for team meetings or collaboration.
Benefits
- competitive pay
- generous health and wellness benefits
- retirement savings plans
- parental leave
- much more!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory frameworkscompliance monitoringinternal auditscorrective action plansstandard operating proceduresproduct lifecycle managementquality systemsdocument management systemsdata qualitydata integrity
Soft skills
attention to detailorganizationdocumentation skillswritten communicationverbal communicationanalytical skillsproblem-solvingself-motivatedcollaborativeadaptable