Caption Health is hiring a
Principal Regulatory Affairs Specialist

About Caption Health

Caption Health’s mission is to detect disease early – when there is the highest potential for impact – by leveraging artificial intelligence and ultrasound. Our breakthrough AI platform enables any healthcare professional to perform high-quality ultrasound exams for early disease detection, in convenient and lower-cost outpatient settings including patients’ homes. It was recognized as one of TIME’s 100 Best Inventions of 2021 and one of Fast Company’s Next Big Things in Health Tech.

Through our work with health plans, providers, patients, and industry partners, we are transforming care, expanding access, and reducing costs.

To learn more, visit captionhealth.com.

We are seeking an experienced RAQA professional to make an impact on our RAQA team! The Principal Regulatory Affairs Specialist is responsible for providing strategic and tactical support of Caption Health’s software-as-a-medical device (SaMD) products. The individual serves as regulatory lead for US FDA, EU and ROW regulatory submissions, reporting directly into the Head of Regulatory Affairs and Quality Assurance.

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Responsibilities

• Prepare and maintain US and non-US product submissions (510(k), Technical Files, Canadian Licenses and International registrations) that meet requirements.
• Evaluate product changes and impact to regulatory submissions worldwide by documenting regulatory decisions and communication/actions required for impacted regions.
• Participate primarily in product development teams, as well as review, analyze, and comment on technical protocols and reports.

• Review, approve, and provide guidance for labeling and advertising.
• Provide support for assure the regulatory compliance in the regions in which medical devices are marketed, including, but not limited to; USA, European Union, Japan, Australia, South Korea, etc.
• Collaborate with parties such as EU notified body officials, consultants, and governmental agencies on product approvals and to ensure audits are successful.
• Maintain internal and external Regulatory Databases as necessary.
• Coach, motivate, and develop individual contributors, including performance management and career development support to individual contributors through coaching and training to help enhance regulatory skill within the department.
• Perform other duties as assigned.

Requirements

• Excellent verbal and written communication skills.
• Excellent understanding a practical application of U.S. and international medical device regulations, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, European Medical Device Regulation, ISO 14971, IEC 62304, IEC 62366, and all applicable domestic and international standards, including California Medical Device license.
• Knowledge and understanding of QSR and ISO quality management system documentation requirements.
• Strong planning and organizational skills.
• Strong teamwork ethic, passion for learning, and desire to seek new challenges.
• Proficient with Microsoft 365 or similar software.

• 7+ years experience in regulatory affairs in the medical device industry
• Experience in preparing and submitting Class II (US) and Class IIb (EU) marketing applications to regulatory agencies. US FDA De Novo experience strongly preferred.
• Bachelor's degree in engineering, computer science, the natural or biological sciences, or equivalent.
• Experience with Software as a Medical Device (SaMD) and/or Artificial Intelligence/Machine Learning (AI/ML) strongly preferred. Experience with cardiovascular or diagnostic imaging products a plus. Experience with ROW submissions strongly preferred.

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Caption Health is an Equal Employment Opportunity employer that proudly pursues and hires a diverse workforce. Caption Health does not make hiring or employment decisions on the basis of race, color, religion or religious belief, ethnic or national origin, nationality, sex, gender, gender-identity, sexual orientation, disability, age, military or veteran status, or any other basis protected by applicable local, state, or federal laws or prohibited by Company policy. Caption Health strives for a healthy and safe workplace and strictly prohibits harassment of any kind. Pursuant to the San Francisco Fair Chance Ordinance and other similar state laws and local ordinances, and its internal policy.

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