Senior Specialist, Regulatory Affairs (Medical Devices)

Location: US MA; open to hybrid or remote work

Salary: $101,600–$152,400 annually, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions.

What you will do

• Develop and implement regional regulatory strategies for new and sustaining products and features.
• Prepare regulatory submissions, including IDEs, 510(k)s, PMAs, Technical Files, Design Dossiers, and other regional device applications.
• Provide regulatory guidance to product and cross-functional new-product-introduction teams.
• Advise stakeholders on regulatory developments, risks, compliance, and documentation requirements.
• Coordinate internal and external resources to support audits, approvals, and compliance requirements.
• Promote continuous improvement and report key performance indicators.

Requirements

• Bachelor’s degree required; an advanced degree is preferred.
• At least 5 years of regulatory affairs experience, preferably in the medical-device industry.
• Experience with electro-mechanical products and regulatory strategy development.
• Strong written and verbal communication skills, with the ability to work with varied stakeholders.
• Ability to create action plans, project deliverables, and responses to regulatory inquiries.
• Approximately 5%–10% travel is required.

Nice to have

• Regulatory Affairs Certification.
• Experience in electrocardiology, defibrillation, or respiratory products.

Culture & Benefits

• Work in a medical-technology organization focused on improving patient outcomes.
• Innovation, self-motivation, and an entrepreneurial spirit are valued.
• Annual bonus eligibility and comprehensive benefits are provided.
• Remote compensation follows applicable federal, state, and local wage laws based on the employee’s primary work location.