Senior Compliance Engineer (Medical Devices)

TL;DR

Senior Compliance Engineer (Medical Devices): Ensuring cardiac assist electromechanical medical devices meet global regulatory, quality, and safety requirements throughout their lifecycle with an accent on electrical safety, design control compliance, labeling, and environmental compliance. Focus on interpreting international standards, conducting compliance impact assessments, and supporting regulatory submissions and audits.

Location: Wayne, NJ, US (1-2 days remote, site-based)

Salary: $120k–$135k

Company

hirify.global provides hospitals and life science institutions with products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science, sold in more than 135 countries.

What you will do

• Lead compliance evaluations for new designs, changes, sustaining engineering, and remediation activities.
• Interpret and apply global standards like IEC 60601 series, EN 1789, GB 9706, UL/CSA for product safety.
• Support labeling, safety markings, environmental compliance (RoHS/REACH), and market-access deliverables.
• Conduct compliance impact assessments in design reviews and ensure audit-ready documentation.
• Guide teams on compliance principles, support CAPA investigations, audits, and regulatory submissions.
• Collaborate with engineering, quality, regulatory, suppliers to maintain compliant product lifecycle.

Requirements

• BS in Systems, Biomedical, Electrical, or Software Engineering with 8+ years related experience (or MS/PhD with 6+ years)
• Demonstrated experience with medical device regulatory and product-safety standards (IEC 60601-1, ISO 14971, etc.).
• Strong understanding of medical electrical safety, risk management, FDA QMSR, ISO 13485, EU MDR.
• Ability to interpret compliance reports, apply risk-based decisions, and prepare technical documentation.
• Excellent communication, cross-functional collaboration, and organizational skills in regulated environment.

Culture & Benefits

• Comprehensive health, dental, vision insurance, 401k with company match, life insurance, short/long-term disability.
• Paid Time Off, parental/caregiver leave, tuition reimbursement, commuter benefits.
• Wellness initiatives, health assistance resources, health/dependent care flexible spending accounts.