What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at ProSomnus® Sleep Technologies?
Company Description
ProSomnus® Sleep Technologies is the leading provider of non-CPAP therapies for treating Obstructive Sleep Apnea (OSA), a condition affecting over 1 billion individuals globally and associated with severe health risks like heart failure, stroke, and diabetes. ProSomnus designs precision-engineered, patient-preferred intraoral medical devices that are non-invasive, easy to use, and tailored to individual anatomy and treatment plans. These FDA-cleared and patented devices are supported by clinical studies demonstrating their efficacy, safety, and high adherence rates. They are widely covered by commercial medical insurance, Medicare, TRICARE, and other government-sponsored healthcare plans, providing access to over 200 million individuals worldwide.
Role Description
This is a full-time, on-site role located in Pleasanton, CA, for a Senior Regulatory Affairs Specialist. The individual in this role will be responsible for preparing and submitting regulatory documentation while ensuring compliance with applicable standards. Key responsibilities include managing regulatory submissions, monitoring evolving regulatory requirements, and collaborating with cross-functional teams. The Senior Regulatory Affairs Specialist will also contribute to developing strategies that align with organizational goals and regulatory guidelines.
Qualifications
- Experience in Regulatory Documentation, including the preparation and review of filing materials and dossiers
- Expertise in Regulatory Compliance and understanding of both domestic and international healthcare regulations
- Familiarity with Regulatory Requirements and their application to the medical device industry
- Proficiency in overseeing Regulatory Affairs operations and strategy
- Proven experience in managing Regulatory Submissions for product approvals
- Strong problem-solving and project management skills
- Bachelor's degree in a relevant field such as Biological Sciences, Engineering, or Regulatory Affairs; advanced degree preferred
- Strong written and verbal communication skills
- Experience in medical device regulatory pathways is a plus
- Ability to collaborate effectively across teams and meet strict deadlines
Applicants must be authorized to work in the U.S. without current or future sponsorship.