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Head of Regulatory Affairs

Chicago, IL

A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we’ve launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

We are seeking a highly motivated and detail-oriented individual to join our team as a Head of Regulatory Affairs. You will work with cross-functional teams to provide technical regulatory leadership and guidance to support new product development as well as existing product platforms. Sibel’s fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative strategies, strong communication skills, teamwork, and more. 

This is a full-time position. The salary range for this role is $160,000 - $180,000, depending on level of experience.

 WHAT YOU WILL BE WORKING ON:

  • Provide regulatory guidance and oversight to research, product development, and manufacturing functions.
  • Prepare, review, and submit regulatory filings, including 510(k) submissions, CE Marking applications, Health Canada MDL applications, and other global marketing authorization applications.
  • Maintain product registrations, technical files, and DHFs.
  • Evaluate changes to existing products.
  • Lead interactions with regulatory agencies, including pre- and post-submission discussions, to ensure timely product marketing authorization.
  • Evaluate proposed and upcoming changes in the global regulatory environment to determine and communicate impact to existing or proposed products as well as overall business impact.
  • Provide regulatory guidance to cross-functional teams during product development, including utilization of standards and review of design documentation, risk management, and verification and validation activities.
  • Ensure product compliance with regulatory requirements regarding advertising, labeling, public disclosures, and corporate communications.
  • Participate in and support internal and third-party audits.
  • Support the development and maintenance of the QMS, ensuring that regulatory requirements are integrated into quality processes and procedures.
  • Create and maintain the company’s global regulatory strategy.
  • Manage a team of regulatory affairs specialists.

ABOUT YOU:

  • Bachelor's degree in a scientific discipline, such as engineering, biological sciences, or a related field. 
  • 8+ years of experience in Regulatory Affairs with solid experience in wearables, wireless, remote monitoring devices, and digital health technologies is highly preferred.
  • QMS Knowledge: Understanding and experience with quality system standards and regulations, including ISO 13485, MDSAP, and 21 CFR Part 820.
  • Regulatory Knowledge: In-depth knowledge of FDA and international medical device regulations (e.g., MDR).
  • Ability to work independently and manage multiple projects and team members simultaneously in a fast-paced startup environment.
  • Attention to Detail: Strong attention to detail and ability to handle complex and technical information accurately.
  • Communication Skills: Effective verbal and written communication skills to collaborate with cross-functional teams, prepare regulatory documents, and communicate with regulatory authorities.

BENEFITS:

  • Medical, dental, vision, life, and disability insurance
  • "Take as much time as you need" policy
  • Simple IRA plan with employer matching
  • Company sponsored events and lunches
  • Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring

Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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