or apply directly on Ekohealth's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 3 days Ekohealth's roles stay open a median of 42 days
- Reposted
- No
- Salary listed
- No 0% of Ekohealth's roles list one
- Ghost-job risk at Ekohealth
- low 0 stale, 0 reposted of 5 open
- Hiring momentum
- 12 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Ekohealth's own lever board since 2026-08-04. Full hiring picture for Ekohealth.
About this role
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.
- benefits
- 1/5
- freshness
- 5/5
- career value
- 4/5
- role clarity
- 5/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Ekohealth as an employer.
What you need
- 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
Worth weighing
- 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
Summarised from Ekohealth's posting. Read the full original.
Listed by Ekohealth on their lever job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.