Senior Director, Regulatory Affairs

Kuros Biosciences, Inc. • Alpharetta, GA

1d • Onsite

About The Position

The Senior Director, Regulatory Affairs is responsible for leading the global regulatory strategy for the company's portfolio of innovative spine and orthopedic products, including medical devices, biologics, combination products, and pipeline technologies. This leader will develop and execute regulatory strategies that support product development, global registrations, lifecycle management, and commercial growth while ensuring compliance with applicable regulations. Reporting to the Chief Operating Officer, the Senior Director will serve as the regulatory subject matter expert and strategic business partner, collaborating closely with Clinical Affairs, Quality Assurance, Research & Development, Operations, Medical Affairs, Marketing, and Executive Leadership. This individual will represent the company before global regulatory authorities and play a key role in advancing innovative therapies to improve patient outcomes. This full-time position is based on-site in Alpharetta, GA and requires approximately 20-30% domestic and international travel.

Requirements

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Biology, Life Sciences, or related scientific discipline required.
• Minimum 12 years of progressive Regulatory Affairs experience within the medical device, biotechnology, or orthopedic industry.
• Minimum 5 years of leadership experience managing regulatory professionals.
• Demonstrated experience supporting Class II and Class III medical devices.
• Experience leading FDA submissions: 510(k), PMA, IDE, and De Novo pathways.
• Strong knowledge of MDR (EU 2017/745) and global regulatory frameworks.
• Experience supporting commercial-stage products and new product development.

Nice To Haves

• Master's degree or PhD preferred.
• RAC (Regulatory Affairs Certification) preferred.
• Experience with biologics and combination products is strongly preferred.

Responsibilities

• Develop and execute global regulatory strategies that support product development, clinical studies, product registrations, and commercialization.
• Lead regulatory planning for new product development from concept through commercialization.
• Provide strategic regulatory guidance for product changes, design modifications, manufacturing changes, and lifecycle management activities.
• Evaluate regulatory risks and provide practical recommendations that align with business objectives.
• Serve as regulatory representative on cross-functional product development teams.
• Lead preparation, review, and submission of regulatory filings including: 510(k), PMA, De Novo, IDE, Technical Documentation, Design Dossiers, International product registrations, Regulatory responses and supplements.
• Oversee regulatory submissions for product changes, labeling updates, manufacturing transfers, and renewals.
• Ensure ongoing compliance with global regulatory requirements throughout the product lifecycle.
• Interpret evolving regulations and communicate business impact to executive leadership.
• Support internal audits and external regulatory inspections.
• Maintain regulatory procedures and ensure alignment with Quality Management System requirements.
• Partner with Clinical Affairs on regulatory aspects of clinical study design.
• Review clinical protocols, investigator brochures, informed consent documents, and clinical reports.
• Provide regulatory input for post-market clinical follow-up activities.
• Support evidence generation strategies for reimbursement and commercialization.
• Build, mentor, and develop a high-performing Regulatory Affairs team.
• Establish department goals, metrics, and operating procedures.
• Manage external regulatory consultants and contract resources.
• Develop departmental budgets and resource plans.
• Foster a collaborative, solutions-oriented culture across the organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior