Senior Manager, Regulatory Affairs (Medtech)

TL;DR

Senior Manager, Regulatory Affairs (Medtech): Leading regulatory strategy and execution for U.S., EU, and ROW market access for the Surgical Workflows Infection Control Consumable portfolio with an accent on FDA and EU MDR compliance. Focus on driving 510(k) submissions, managing health authority interactions, and integrating regulatory risk management into the product lifecycle.

Location: Remote (Must be based in the USA)

Salary: $161,920.00 - $202,400.00 annually + 25% bonus target

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Develop and execute comprehensive global device classifications and regulatory strategies for SWICC products.
• Drive U.S. submissions (e.g., 510(k), De Novo) and global filings for FDA Class I & II and EU MDR Class I, IIa, and IIb devices.
• Serve as the regulatory authority in cross-functional teams, embedding requirements into design controls, technical documentation, and risk management.
• Act as the primary interface with the FDA, EU Notified Bodies, and other competent authorities.
• Oversee post-market regulatory compliance, including U.S. corrections, removals, and MDR reporting.
• Mentor and develop regulatory team members while advocating for the integration of regulatory best practices.

Requirements

• Must be based in the United States
• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
• 8–10+ years of progressive regulatory experience in the medical device field.
• Demonstrated experience leading FDA Class I and II submissions (e.g., 510(k)) and EU MDR (2017/745) Technical Documentation.
• Direct engagement experience with the FDA and experience interacting with EU Notified Bodies.
• Deep technical knowledge of 21 CFR 820/QMSR, ISO 13485, and ISO 14971.

Nice to have

• Advanced degree in a relevant field.
• RAC certification or equivalent.
• Experience with ROW competent authority interactions.

Culture & Benefits

• Comprehensive health, dental, and vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and wellness initiatives.
• Parental and caregiver leave.
• Tuition reimbursement.
• Fully remote work arrangement (5 days at home).