Manager, Regulatory Affairs (Medical Devices)

Location: Remote - US

Salary: $127,000–$165,000 per year

Company

hirify.global is a digital healthcare company developing wearable biosensors, cloud-based data analytics, and proprietary algorithms for cardiac health monitoring.

What you will do

• Develop and execute regulatory strategies for new and modified wearable medical devices and AI Software as a Medical Device products.
• Lead FDA 510(k) and pre-submission activities, EU MDR technical documentation, and other domestic and international filings.
• Manage regulatory associates as needed, including work planning, guidance, execution, and talent development.
• Act as a regulatory subject matter expert for AI, SaMD, and cybersecurity while establishing compliance processes with stakeholders.
• Review advertising, promotional materials, product design changes, SOPs, and lifecycle management strategies for regulatory compliance.
• Interact with regulatory authorities and support internal and external audits.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related field; a master’s degree may qualify with six years of relevant experience.
• At least 8–10 years of US and/or EU regulatory affairs experience with a bachelor’s degree, or at least six years with a master’s degree.
• Experience with SaMD, new product development, risk-based regulatory strategies, and authorship of FDA 510(k) submissions.
• Competence with 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA, and other medical device standards.
• Strong project management, problem-solving, organizational, written, and oral communication skills.
• Willingness to travel approximately 5–10% when required.

Nice to have

• Wearable medical device experience.
• Familiarity with medical device regulations in LATAM, Asia-Pacific, EMEA, and other global markets.
• Experience supporting audits.

Culture & Benefits

• Full-time employment with medical, dental, and vision insurance.
• Paid holidays and paid time off.
• 401(k) with company match.
• Employee Stock Purchase Plan.
• Organizational and cultural committee events.