Senior Manager, Regulatory Affairs (Medical Devices)

TL;DR

Senior Manager, Regulatory Affairs (Medical Devices): Leading regulatory strategy and execution for U.S., EU, and ROW market access for Surgical Workflows Infection Control Consumable products with an accent on FDA and EU MDR compliance. Focus on managing global filings, integrating regulatory risk into product lifecycles, and leading health authority interactions.

Location: Remote (Must be based in the US)

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

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 global regulatory strategies for SWICC products to align regulatory requirements with business objectives.
• Drive U.S. submissions (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, ensuring compliance in design controls, technical documentation, and risk management.
• Manage primary interactions with the FDA, EU Notified Bodies, and other global competent authorities.
• Oversee post-market compliance, including corrections, removals, and MDR reporting obligations.
• Mentor and develop regulatory team members to foster strategic thinking and subject-matter expertise.

Requirements

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

Nice to have

• Advanced degree.
• RAC certification or equivalent.
• Experience with ROW competent authority interactions.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k plan with company match.
• Paid Time Off and parental/caregiver leave.
• Wellness initiatives and health assistance resources.
• Tuition reimbursement.