Quality & Regulatory Specialist

Overview

We are partnering with a growth-stage medical device manufacturer to recruit a Regulatory Affairs Specialist to join their team in New York State. Our client designs and manufactures regulated medical devices distributed through clinical and hospital channels and has an established, active installed base. As the business scales, they are expanding their Regulatory & Quality operations to support increasing change activity, audit readiness, and global compliance needs.

This is a hands‑on, high‑ownership individual contributor role with visible impact across the regulatory and quality spectrum. The right person will be execution‑driven, comfortable in a lean cross‑functional environment, and motivated by accountability and broad scope.

Quality Management System (QMS)

• Track and drive CAPAs, nonconformances, and corrective actions through to closure
• Maintain and support an ISO 13485‑aligned QMS, including document and record control
• Support training record upkeep and assist with onboarding new employees
• Maintain quality metrics and contribute to trend analysis and management reporting

Audit & Compliance

• Assist with external audit preparation, participation, and follow‑up activities
• Support the internal audit program, including planning and execution
• Help maintain North American compliance records and overall audit‑readiness status

Regulatory & Technical Documentation

• Support UDI/GUDID maintenance and labeling review workflows
• Contribute to change control and supplier quality documentation workflows
• Support supplier and contract manufacturer quality documentation activities
• Assist with monitoring evolving compliance requirements and integrating updates into internal processes
• Support risk management files, DHF updates, and design change documentation
• Contribute to EU MDR technical documentation and notified body audit readiness (as applicable)

Cross‑Functional Collaboration

• Serve as a dependable execution partner across product, supplier, and change control activities
• Work alongside Engineering, Operations, and Regulatory leadership in weekly and ad hoc team meetings
• Operate with clear, direct communication and shared ownership in a lean organizational structure

• Experience with eQMS and/or document control systems
• Bachelor’s degree in a relevant technical, engineering, or life sciences discipline (or equivalent demonstrated experience in medical device regulatory/quality)
• 3–7 years of hands‑on experience in medical device quality or regulatory affairs in an ISO/FDA‑regulated environment
• Practical working knowledge of ISO 13485 QMS processes, including document control, CAPA, nonconformance management, and change control
• Direct exposure to global audit programs (e.g., MDSAP—supporting, preparing for, and/or participating)
• Proven ability to produce and maintain detailed, audit‑ready documentation
• Ownership‑oriented working style with the ability to manage tasks independently through completion
• Comfortable escalating compliance concerns and communicating effectively in a cross‑functional, lean environment
• U.S. work authorization required; standard pre‑employment background screening applies

• Familiarity with applicable quality system regulations (e.g., FDA QSR / 21 CFR Part 820) requirements
• RAC, ASQ (CQA or CQE), or ISO 13485 internal/lead auditor certification
• ISO 14971 risk management experience or certification
• Experience in a regulated medical device environment
• Background in a small‑to‑mid‑sized, privately held, or growth‑stage company where roles are broad and cross‑functional
• Experience with regulated health technology hardware/software (e.g., connected devices, diagnostics, monitoring, or adjacent platforms)

Salary: $75,000 – $95,000 base salary, commensurate with experience.

Benefits:
Comprehensive benefits package including medical, dental, vision, retirement plan, and paid time off.

Equal Employment Opportunity Statement
:
Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants…