Regulatory and Product Compliance Specialist

About the Role:

As part of the medical team reporting to the Manager of Clinical Projects, with visibility to the Chief Medical Officer and General Counsel, this role serves 2 important functions: 1) to maintain strong regulatory and GCP compliance for all ongoing research initiatives within Aura; and 2) to coordinate and oversee the broader medical-legal-regulatory (MLR) review process for product development, marketing, and communications. As part of the research support function, the team member will manage all aspects of ongoing and new IRB submissions and correspondence. As part of the MLR coordination process, the team member will work cross-functionally to ensure that new materials (product messaging, marketing campaigns, scientific communications, press releases, etc.) are reviewed through the proper software systems and maintained in accordance with good practice. This part of the role will also help to conduct periodic internal reviews/audits to ensure all materials are up to date and compliant with guiding regulations. This is a unique opportunity to develop and implement processes to ensure ongoing research compliance and data quality/integrity that directly influences product development! If you are passionate about translating research discovery into practical application with broad reach, we hope to hear from you!

About the Team

You will join a mission-driven medical team focused on building best-in-class products to help parents and kids navigate the digital world safely. Partnering closely with cross-functional teams, you will play a critical role in setting clinical safety standards, ensuring health information quality, and maintaining compliance with all relevant regulations and guidance.

Responsibilities

• 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.

Qualifications

• 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.

Aura is committed to offering a generous package to support our employees in all aspects of their life in and out of work. Our packages offer competitive pay, generous health and wellness benefits, retirement savings plans, parental leave and much more! Pay range for this position is $85,000-115,000, but may vary depending on job-related knowledge, skills, experience and location. 

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