RemoteLeaf Logo
Log in Sign up

Senior Regulatory Affairs Specialist

3 hours, 33 minutes ago
United States
Full-time
Senior
Compliance Manager
Operations
Apply Now
Eko Health

Eko Health

Eko Health is a medical equipment manufacturing company that specializes in digital stethoscopes, AI disease detection, and telehealth solutions. They provide industry-leading tools for healthcare professionals to detect cardiovascular and pulmonary di...

Health Care Providers & Services
51-250
Founded 2014
$128M raised
View All Jobs

Description

  • Lead QMS and regulatory remediation programs and streamline global procedures.
  • Revise and consolidate SOPs covering DHF, design and development, PMS, labeling/UDI, EUDAMED, and regulatory strategy.
  • Maintain regulatory documentation and the Global Regulatory Submissions & Deficiencies Database.
  • Develop registration strategies and support submissions across the EU, UK, Canada, APAC, and LATAM.
  • Manage Notified Body and EU Authorized Representative interactions, including technical file reviews, change notifications, and CE/DoC updates.
  • Support regulatory intelligence and evaluation for the global Eko Vet+ rollout.
  • Represent Regulatory Affairs on hardware and AI/software product development teams.
  • Standardize claims matrices, IFU restrictions, and advertising and promotional review processes.
  • Evaluate and implement regulatory information management systems and AI-enabled workflows.
  • Ensure compliance with company policies and applicable laws.

Requirements

  • Bachelor’s or advanced degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical discipline.
  • 5–8+ years of progressive regulatory affairs experience in medical devices, digital health, and/or SaMD.
  • Working knowledge of FDA 21 CFR 820/QMSR, EU MDR 2017/745, ISO 13485, and global regulatory submissions.
  • Direct experience preparing or submitting 510(k)s, Q-Subs, De Novo applications, and Technical Files.
  • Experience managing Notified Body reviews.
  • Track record leading major QMS remediation programs and global market entries.
  • Strong communication, organizational, and problem-solving skills.
  • RAC certification preferred.
  • Experience in a startup or high-growth environment preferred.
  • Ability to perform the role with or without reasonable accommodation; remote work with expected travel.

Benefits

  • Generous paid time off.
  • Stock incentive plan.
  • Medical, dental, vision, disability, and life insurance.
  • One Medical membership.
  • Parental leave.
  • 401(k) matching.
  • Learning and development stipend.
  • Remote position with expected travel.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

CertiK

Director of AML & Virtual Asset Compliance

CertiK

CertiK is seeking a senior compliance and financial crime leader to expand AML, virtual asset compliance, and blockchain risk management programs while advising clients, regulators, and industry stakeholders.

Singapore United States Hong Kong Full-time Executive Compliance Manager
$150k-$220k
Penetration Testing
3 hours, 18 minutes ago
Alphasense

Compliance Analyst (Night Shift- Pacific Time)

Alphasense 51-250 Industrial Conglomerates

AlphaSense’s Tegus Compliance Team is hiring a Compliance Analyst to review expert-call transcripts, identify sensitive information, and support compliant content generation in a fast-paced environment.

United States Full-time Junior Compliance Manager
$60k-$60k
3 hours, 18 minutes ago
Bybit

Money Laundering Reporting Officer

Bybit 1K-5K Capital Markets

Bybit is hiring a Brazil-based senior AML/CFT and sanctions compliance professional to oversee regulatory compliance, risk controls, investigations, and reporting for its global cryptocurrency and digital finance platform.

Brazil Full-time Senior Compliance Manager
1 day, 3 hours ago
Bybit

Compliance Officer, India

Bybit 1K-5K Capital Markets

Bybit is seeking an experienced MLRO / Principal Officer to lead AML/CFT and financial crime compliance for its digital asset payments business in India, including regulatory reporting and engagement with FIU-IND.

India Full-time Lead Compliance Manager
1 day, 4 hours ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers