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

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).

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 and Non-Discrimination Policy

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 will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status.

Commitment to Diversity: Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected.

Reasonable Accommodations: Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations.

Compensation Information: For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar roles. Salary ranges may vary based on role and location.

Compliance with Laws: Both Keller Executive Search and our clients comply with federal, state, and local laws governing nondiscrimination in employment. This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Workplace Harassment: Both Keller Executive Search and our clients expressly prohibit any form of workplace harassment based on race, skin color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.

E-Verify Participation: Keller Executive Search and/or our clients may participate in E-Verify. Information about E-Verify participation will be provided during the application process where applicable.

Use of Artificial Intelligence in Recruitment: Keller Executive Search and our clients may use artificial intelligence (AI) tools to assist in the recruitment and candidate evaluation process. These tools are used exclusively to support human decision-making by helping to review and assess candidate qualifications and materials. AI is never used to automatically reject, disqualify, or make final hiring decisions about candidates. All AI-assisted evaluations are reviewed by experienced recruitment professionals, and all hiring decisions are made by qualified human recruiters. Our use of AI is designed to enhance fairness, consistency, and efficiency while maintaining our commitment to equal employment opportunity and non-discrimination principles.

Privacy and Pay Equity:

California Residents: For more information about the categories of personal information we collect for recruiting and employment purposes, please review our Privacy Policy at www.kellerexecutivesearch.com.

Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available.

Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws.

State-Specific Information:

Rhode Island: We do not request or require salary history from applicants.

Connecticut: We provide wage range information upon request or before discussing compensation.

New Jersey: We do not inquire about salary history unless voluntarily disclosed.

Veteran Status: Both Keller Executive Search and our clients provide equal employment opportunities to veterans and comply with applicable state laws regarding veteran preference in employment. If you are a veteran, please inform us during the application process.

Genetic Information: In accordance with federal and state laws, both Keller Executive Search and our clients do not discriminate based on genetic information. We do not request or require genetic information from applicants or employees, except as permitted by law.

Local Laws: Both Keller Executive Search and our clients comply with all applicable local laws and ordinances regarding employment practices in the areas where we operate.

Note: This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.