HHiring Reality
← Ekohealth

Senior Regulatory Affairs Specialist

Ekohealth
Location
Remote, US
Posted
7 days ago
Department
Regulatory & Quality
What they actually want (must-haves)
  • Bachelor's or Master's/advanced degree in Engineering, Life Sciences, Regulatory Affairs, or related technical discipline
  • 5–8+ years of progressive regulatory affairs experience in medical devices, digital health, and/or SaMD
  • Strong working knowledge of FDA 21 CFR 820 / QMSR, EU MDR 2017/745, ISO 13485, and global regulatory submissions
  • Direct experience writing/submitting 510(k)s, Q-Subs, De Novo, Technical Files, and managing Notified Body reviews
  • Proven track record leading major QMS remediation programs and global market entries
  • Strong communication, organizational, and problem-solving skills
Nice to have
  • RAC (Regulatory Affairs Certification) preferred
  • Experience in a startup or high-growth environment
What the job really is

As a Senior Regulatory Affairs Specialist at Eko Health, you will lead regulatory remediation efforts and oversee global expansion strategies for medical devices and software platforms. Your role will involve managing regulatory documentation, ensuring compliance with international standards, and collaborating with project teams on product releases. You will also engage with regulatory bodies and contribute to the development of streamlined workflows within the company.

Things to weigh
  • No salary listed
  • The role involves significant regulatory responsibilities which may require extensive interaction with global regulatory bodies
  • Job duties may change at any time with or without notice
Job score3/5
Benefits1/5
Freshness5/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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