Lead Global Regulatory Affairs Specialist

2 weeks ago

San Francisco, California, United States Eko Devices Full time

About Eko Devices: Eko is committed to enhancing the capabilities of healthcare professionals by providing cutting-edge digital solutions for cardiopulmonary assessment. Our innovative platform empowers clinicians to accurately identify and manage cardiopulmonary conditions, ensuring optimal patient care.

Company Growth: With substantial backing exceeding $125 million from esteemed partners, Eko has rapidly expanded, now serving over 135,000 clinicians across 4,000 hospitals in the U.S. Our diverse and talented team is dedicated to our mission of making high-quality healthcare accessible to all.

Role Overview: As a Lead Global Regulatory Affairs Specialist, you will play a crucial role in steering global regulatory submissions and formulating strategic regulatory guidance. Your responsibilities will include:

  • Leading the development of technical documentation and global submission materials.
  • Representing Regulatory Affairs in project teams throughout the product lifecycle, including design and risk assessments.
  • Overseeing the regulatory aspects of change management processes and submissions.
  • Collaborating with internal and external stakeholders to ensure project timelines and goals are met.
  • Managing the compilation and submission of regulatory documents to ensure compliance with authority requirements.
  • Maintaining and developing relevant Standard Operating Procedures (SOPs) and guidance documents.
  • Assisting with submissions and post-market activities for U.S. FDA, EU MDR, and UKCA.

Qualifications: The ideal candidate will possess:

  • A Bachelor’s degree or higher in a scientific discipline.
  • A minimum of 5 years of experience in Regulatory Affairs, specifically within the medical device or digital health sectors.
  • A proven track record of successful marketing application submissions.
  • In-depth knowledge of U.S. and EU regulatory frameworks.
  • A proactive approach with strong attention to detail and strategic thinking capabilities.
  • Excellent communication skills, both verbal and written, for effective interaction with various stakeholders.
  • The ability to thrive in a dynamic, smaller organization while managing ambiguity.

Benefits: Eko offers a range of benefits, including:

  • Recognition as a Great Place to Work.
  • Comprehensive medical, dental, and vision coverage.
  • Paid time off and parental leave.
  • 401k matching and wellness programs.
  • Learning and development opportunities.

Eko is dedicated to transforming the landscape of cardiovascular care through innovative technology, ensuring that healthcare providers have the tools they need to deliver exceptional patient outcomes.

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