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← Kuros Biosciences, Inc.

Senior Director, Regulatory Affairs

Kuros Biosciences, Inc.
Location
Alpharetta, GA
Posted
17 days ago
Department
2200 - Regulatory
What they actually want (must-haves)
  • Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Biology, Life Sciences, or related scientific discipline
  • 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
Nice to have
  • Master's degree or PhD
  • RAC (Regulatory Affairs Certification)
  • Experience with biologics and combination products is strongly preferred
  • Experience supporting commercial-stage products and new product development
What the job really is

The Senior Director, Regulatory Affairs will lead the global regulatory strategy for innovative spine and orthopedic products, ensuring compliance and supporting product development and commercialization. This role involves collaborating with various departments, overseeing regulatory submissions, and managing a high-performing team while representing the company to global regulatory authorities.

Things to weigh
  • Requires 20-30% domestic and international travel
  • On-site position in Alpharetta, GA
  • Physical demands may include lifting items over 50 pounds
Job score2.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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