Senior Specialist, Regulatory Affairs (Medical Devices)

Location: US, Massachusetts; open to hybrid or remote work

Annual salary: $101,600–$152,400, 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 IDE, 510(k), PMA, Technical File, Design Dossier, and other regional device applications.
• Provide regulatory guidance to product, NPI, and cross-functional project teams.
• Assess regulatory risks, support compliance activities, and coordinate audit requirements.
• Monitor regulations and guidance, communicate regulatory developments, and develop approval strategies.
• Promote continuous improvement and report on related KPIs.

Requirements

• Bachelor’s degree required; advanced degree preferred.
• At least 5 years of regulatory affairs experience, preferably in the medical device industry.
• Proven experience with electro-mechanical products.
• Experience creating regulatory strategies, action plans, project deliverables, and responses to regulatory inquiries.
• Strong written and verbal communication skills for working with varied stakeholders.
• Travel of approximately 5%–10% is required.

Nice to have

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

Culture & Benefits

• Work in a purpose-driven environment focused on improving patient outcomes and saving lives.
• Culture values innovation, self-motivation, and an entrepreneurial spirit.
• Annual bonus eligibility and comprehensive benefits.
• Products and services support customers in more than 140 countries.