Regulatory Affairs Specialist

Overview

We are partnering with a growth-stage medical device manufacturer to identify a Regulatory Affairs Specialist for their team in New York State. This organization designs and manufactures regulated medical devices distributed through clinical and hospital channels. Products are commercially established with an active installed base. The company is expanding its Regulatory & Quality operations to support increased change activity, audit readiness, and global compliance requirements.

The company is in a pivotal operational phase and is building out its Regulatory and Quality execution capacity to match an expanding compliance workload. This is a hands-on, high-ownership individual contributor role with visible impact across the full regulatory and quality spectrum.

 If you are an execution-focused regulatory and quality professional who thrives in a lean, cross-functional environment and wants real accountability and breadth.

Key Responsibilities

Quality Management System (QMS)

• Maintain and support the ISO 13485-compliant QMS, including document and record control
• Track and manage CAPAs, nonconformances, and corrective actions through to closure
• Maintain quality metrics and contribute to trend analysis and management reporting
• Support training record maintenance and assist with new employee onboarding

Audit & Compliance

• Support internal audit programme, including planning and execution
• Assist with external audit preparation, active participation, and follow-up
• Help maintain North American regulatory compliance records to audit-ready status

Regulatory & Technical Documentation

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

Cross-Functional Collaboration

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

Requirements

Required Qualifications

• Bachelor's degree in a relevant technical, engineering, or life sciences field — or equivalent demonstrated experience in a medical device regulatory and quality function
• 3 to 7 years of hands-on experience in medical device quality or regulatory affairs within 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, or participating in)
• Experience with eQMS or document control systems
• Demonstrated ability to produce and maintain audit-ready documentation with high attention to detail
• Execution-oriented working style — capable of managing assigned tasks independently and taking ownership through to completion
• Comfortable raising compliance concerns and communicating clearly in a cross-functional, lean environment
• US work authorisation required; standard pre-employment background screening applies

Preferred Qualifications

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

Benefits

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

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

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