Sr. Regulatory Affairs Specialist (Medical Devices)

TL;DR

Sr. Regulatory Affairs Specialist (Medical Devices): Managing domestic and international compliance activities and regulatory strategies for new devices and post-market changes with an accent on FDA and EU MDR filings. Focus on negotiating with regulatory agencies, preparing comprehensive submissions such as 510(k) and PMA, and ensuring strict ISO 13485 compliance.

Location: Fully remote (Must be based in the US)

Salary: $120,000–$150,000

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows in intensive care and cardiovascular procedures.

What you will do

• Develop and communicate comprehensive regulatory strategies for new medical devices and post-market changes.
• Prepare and manage regulatory filings including 510(k), PMA, EuMDR, PMA supplements, and Q-subs.
• Negotiate directly with governmental agencies and notified bodies regarding regulatory submissions.
• Review and approve labeling, promotional materials, and product modifications for compliance.
• Support engineering changes and field correction/recall activities in alignment with RA/QA practices.
• Ensure all documentation complies with FDA 21CFR Part 820, EU MDR, and ISO 13485 standards.

Requirements

• Bachelor’s degree with at least 4 years of directly related Regulatory Affairs experience in medical devices (or 10+ years without a degree).
• Proven experience with the preparation and approval of 510(k) or PMA submissions.
• In-depth knowledge of FDA 21CFR Part 820, EU MDR, MDSAP, and ISO 13485.
• Proficiency in MS Office applications.
• Strong negotiation and analytical skills for interacting with regulatory entities.
• Must be eligible to work in the US.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and wellness initiative resources.
• Parental and caregiver leave.
• Tuition reimbursement and life insurance.