Senior Manager, Regulatory Affairs

TL;DR

Senior Manager, Regulatory Affairs (Medical Devices): Provide regulatory strategy and execution leadership for U.S., EU, and ROW market access and compliance across a surgical workflows infection control consumables portfolio with an accent on FDA and EU MDR regulatory pathways, technical documentation, and health authority interactions. Focus on integrating regulatory risk management early in the product lifecycle, driving submissions and post-market compliance, and mentoring a regulatory team to ensure audit-ready regulatory integrity.

Location: Nashua, NH, 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 to improve clinical results and optimize workflows.

What you will do

• Lead global regulatory strategy and market access for SWICC products, including device classification and regulatory pathway development for FDA and EU MDR.
• Drive U.S. submissions (e.g., 510(k), De Novo when applicable) and global filings, ensuring defensible regulatory routes for FDA Class I & II and EU MDR Class I, IIa, and IIb devices.
• Embed regulatory requirements into product development and lifecycle governance, including design controls, technical documentation, ISO 14971 risk management, labeling, and verification/validation planning.
• Oversee dossier and technical documentation readiness for U.S. and EU markets; manage pre-submission interactions, responses, deficiency management, and post-submission negotiations with authorities.
• Own post-market regulatory compliance and health authority affairs, including U.S. corrections/removals and MDR reporting, plus support for EU FSCA/competent authority interactions and inspections/audits.
• Mentor and develop regulatory team members and improve regulatory processes, templates, and tools across the product portfolio.

Requirements

• FDA and Notified Body audit experience.
• Deep knowledge of 21 CFR 820/QMSR, 21 CFR 807, 803, 806; EU MDR (2017/745); ISO 13485 and ISO 14971.
• Experience leading FDA Class I and II submissions (e.g., 510(k)) and EU MDR (2017/745) technical documentation/conformity assessment.
• Direct engagement with FDA required; experience interacting with EU Notified Bodies required; ROW competent authority interactions preferred.
• Advanced regulatory writing and documentation oversight capability, including regulatory planning, strategy submissions, and negotiation skills.
• 8–10+ years of progressive regulatory experience in the medical device field; bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline (advanced degree preferred).

Culture & Benefits

• Fully remote work arrangement with 5 days at home (#LI-Remote), with office environment duties as needed.
• Health, Dental, and Vision insurance; 401k plan with company match; Life Insurance; Short and Long Term Disability benefits.
• Paid Time Off, wellness initiative & health assistance resources, and tuition reimbursement.
• Health and Dependent Care Flexible Spending Accounts, commuter benefits, and parental/caregiver leave.
• May require periodic travel (up to ~20%) for audits, regulatory meetings, and cross-site collaboration.

Hiring process

• Application review followed by interviews to assess regulatory strategy, submission experience, and cross-functional leadership.
• Evaluation of regulatory documentation/writing capability and experience with FDA/EU MDR and health authority interactions.