Regulatory Consultant –
Senior Manager
Remote – United States – Full-Time Position
Company Overview
Accorto Regulatory Solutions is a fully-remote, boutique regulatory and compliance firm whose mission is to help small to mid-sized domestic and international companies bring FDA-regulated products to market through innovative, cost-effective regulatory application strategies. We ensure our clients’ products remain on the market by focusing on continued regulatory compliance throughout the product lifecycle. Our expertise in navigating the FDA’s complex processes helps entrepreneurs and companies without in-house regulatory staff (or who need additional regulatory resources), as well as overseas companies, successfully enter the US market.
Position Overview
Accorto Regulatory Solutions is seeking a highly skilled and motivated Regulatory Consultant Senior Manager to lead our U.S. FDA regulatory application development team. This is a working supervisor role, responsible for overseeing and contributing to client-facing projects in the medical device, combination device, and over-the-counter drug sectors. The successful candidate will ensure the team remains focused on technical execution while maintaining high standards of quality, compliance, and client satisfaction.
Key Responsibilities:
- Team Leadership & Oversight
- Lead a small regulatory affairs team, balancing supervisory responsibilities with direct project contributions.
- Assess project requirements and delegate tasks based on team workload and qualifications.
- Help drive operational decision-making and planning within the department, overseeing workflow, assignments, and staff development with minimal direction.
- Monitor team performance, ensure timelines are met, and review deliverables for quality.
- Continuously evaluate team capabilities and recommend training or capacity expansion.
- Client & Project Engagement
- Attend client inquiry meetings to understand project scope and translate it into actionable plans.
- Partner with the Business Development team in responding to project inquiries, proposals, and client discussions.
- Participate in management planning and client update meetings to track progress and resolve hurdles.
- Prepare for and attend FDA meetings (e.g., Q-subs) as needed.
- Regulatory Strategy & Execution
- Guide development of regulatory pathways and application strategies.
- Oversee testing strategy development, protocol creation, and application drafting.
- Manage FDA communications and ensure alignment with regulatory expectations.
- Operational Excellence
- Conduct monthly project hours reviews to identify budget variances and recommend corrective actions.
- Recommend and implement process improvements within the regulatory team.
- Contribute directly to regulatory research, writing, and FDA correspondence when needed.
Required Skills and Qualifications:
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- Deep understanding of U.S. FDA regulatory pathways for medical devices, combination products, and OTC.
- Ability to interpret scientific data, study reports, and statistical analyses.
- Strong technical and business writing skills.
- Excellent critical thinking and problem-solving abilities.
- Comfort navigating ambiguous regulatory guidance to develop optimal strategies.
- Proven ability to manage shifting priorities while maintaining client satisfaction.
- Experience influencing cross-functional teams and managing direct reports.
- Strong interpersonal and client communication skills.
- Bachelor’s degree (or higher) in Engineering, Science, or Regulatory Affairs.
- 2+ years of experience in regulatory affairs in the medical device industry, 2+ years supervising a team of technical professionals.
Accorto Regulatory Solutions is committed to creating a diverse environment and is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.
