Senior Global Regulatory Specialist
San Francisco Bay Area
Regulatory & Quality /
Full Time /
Hybrid
At Eko, we’re dedicated to providing healthcare professionals with industry leading digital tools to hear and understand their patients’ hearts and lungs. With our platform, clinicians can detect cardiopulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible.
With over $165M in funding from partners like 3M and the Mayo Clinic, Eko has become one of the fastest growing digital health companies, doubling our customer base in the last year to over 500,000 clinicians across 4,000 U.S. hospitals. We’ve built a tremendously talented, diverse, and mission driven team and are proud to be certified as a Great Place to Work®. Together we are committed to investing in each other and our mission to ensure all patients have access to high quality care.
Eko Health is a venture-backed digital health company revolutionizing cardiovascular care through innovative technology. Our comprehensive platform includes non-invasive monitoring devices, clinical software, and decision support tools, such as the revolutionary Eko Core Digital Stethoscope, recognized as a TIME Magazine “Best Invention of the Year.” Our latest FDA-cleared DUO device combines a digital stethoscope with an ECG cardiac monitor and AI, providing seamless in-clinic and at-home monitoring for 28 million heart disease patients. Eko Health's commitment to improving patient outcomes has made us a trusted partner for over 1000 hospitals and health systems worldwide.
As a Senior Global Regulatory Specialist at Eko, You Will:
- Assist/lead global regulatory submissions and build regulatory guidance and strategy.
- Assist/lead creation of technical files and global internal and external submission documents.
- Represent Regulatory Affairs on assigned project teams through all phases of product life cycle, including but not limited to design reviews, risk file reviews, V&V reviews, post-market surveillance review.
- Lead and assess regulatory implications of the change management process internally and change management notifications and amendment submissions globally.
- Assist with regulatory project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time.
- Work with internal and external partners on planning and execution of projects and help with timely communication with external partners and present the company in meetings.
- Assist/Oversee compilation, electronic processing, and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements.
- Oversee the maintenance and creation of relevant SOPs, Work Instructions, and other necessary guidance.
- Assist with US FDA, EU MDR and UKCA submissions, maintenance, and post-market activities.
As a Senior Global Regulatory Specialist at Eko, You Have:
- Bachelor or higher degree in a scientific field required.
- 5+ years of experience in Regulatory/Global Regulatory Affairs for medical devices, and/or software as a medical device and digital health.
- Successful track record of filing Marketing Applications.
- Must have strong regulatory experience and knowledge with US and EU (MDD/MDR)
- Self-initiator with a positive attitude and willing to roll up your sleeves to get the job done; ability to pay close attention to detail and step back and think strategically.
- Strong interpersonal verbal, written and presentation skills in communication with internal and external parties.
- Must be comfortable working for a small organization, and able to handle ambiguity.
Benefits and Perks We Offer:
- Eko was recognized by “Great Place to Work” in 2020 and 2021
- Paid-time off
- Medical/Dental/Vision, Disability + Life Insurance
- One Medical membership
- Paid Parental Leave
- 401k Matching
- Company sponsored Commuter Benefit Programs
- Employee Assistance Programs
- Remote Work Allowance
- Flexible schedules
- Wellness perks (Wellhub (FKA GymPass), Carrott, Rightway, OneMedical, Fetch, SmartSpend, SoFi)
- Learning and Development stipend
$110,000 - $123,000 a year
Eko is elevating the way clinicians detect and monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI-powered analysis. Its FDA cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in-person, and through telehealth. The company is headquartered in Oakland, California and privately-held, with investments from ARTIS Ventures, NTT Venture Capital, DigiTx Ventures, Mayo Clinic, Sutter Health and others.
Eko is proud to be an equal opportunity employer and welcome people of different backgrounds, experiences, abilities and perspectives. We celebrate diversity and are committed to building a diverse and inclusive team.
