Senior Regulatory Affairs & Compliance Specialist

Specialist Staffing Group; New York (NY); On-site; USD 110,000 - 190,000; Full time

Job summary

Specialist Staffing Group is seeking a seasoned regulatory affairs professional in New York, NY to support regulatory compliance and quality systems across product development, manufacturing, and commercialization. In this role you will conduct risk assessments, manage regulatory submissions, and coordinate cross‑functional compliance initiatives with engineering, operations, and quality teams.

The position offers a permanent, full‑time arrangement with a salary range of $110,000–$190,000 per

Qualifications

• 5 to 10 years of regulatory affairs, compliance, or quality assurance experience.
• Knowledge of regulatory frameworks and compliance requirements in the field.
• Experience with risk assessment methodologies and audits.
• Strong understanding of quality system implementation and maintenance.
• Excellent written and verbal communication skills.
• Authorization to work in the United States.
• Nice-to-have CCP or equivalent regulatory certification.

Responsibilities

• Supporting the development and maintenance of quality systems and compliance frameworks aligned with regulatory requirements
• Conducting risk assessments and audit activities to identify compliance gaps and improvement opportunities
• Preparing and managing regulatory submissions, documentation, and correspondence with regulatory bodies
• Coordinating cross-functional compliance initiatives with engineering, operations, and quality teams
• Monitoring regulatory changes and communicating implications to relevant stakeholders
• Contributing to the implementation of corrective and preventive actions (CAPA)
• Maintaining regulatory records and ensuring documentation traceability and completeness
• Advising on regulatory requirements that affect product development, manufacturing, and commercialization

Skills

Regulatory affairs

Quality assurance

Risk management

Audit management

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Job description

Specialist Staffing Group is seeking a seasoned regulatory affairs professional in New York, NY to support regulatory compliance and quality systems across product development, manufacturing, and commercialization. In this role you will conduct risk assessments, manage regulatory submissions, and coordinate cross‑functional compliance initiatives with engineering, operations, and quality teams.

The position offers a permanent, full‑time arrangement with a salary range of $110,000–$190,000 per