Regulatory 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

About the opportunity

Roles of this type typically support organizations in navigating regulatory requirements, managing compliance obligations, and implementing quality assurance and risk assessment protocols. You could work within a collaborative environment where regulatory knowledge directly influences product development, operational delivery, and organizational risk management. The work could involve partnering across engineering, quality, operations, and leadership to ensure regulatory adherence under relevant frameworks and industry standards, with scope to contribute to raising compliance standards across the organization.

Typical role overview

• Location: New York, New York, USA
• Type: Permanent · Full-time
• Salary: $110,000 - $190,000 per year, dependent on experience
• Domain: Regulatory affairs · compliance · risk management

What you would do

• 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

What you could bring

• Must-have5 to 10 years of regulatory affairs, compliance, or quality assurance experience
• Demonstrated knowledge of regulatory frameworks and compliance requirements in your field
• Experience with risk assessment methodologies and audit management
• Strong understanding of quality system implementation and maintenance
• Excellent written and verbal communication skills
• Bachelor's degree in engineering, business, finance, accounting, or a related field
• Authorization to work in the United States
• Nice-to-haveCertified Compliance Professional (CCP) or equivalent regulatory certification
• Experience with specific industry regulations relevant to your sector
• Knowledge of QARA (Quality Assurance and Regulatory Affairs) processes
• Master's degree in a related discipline
• Experience mentoring junior compliance or regulatory staff

What roles of this type could offer

Opportunity to directly influence organizational compliance posture and risk management strategyInvolvement in cross-functional projects that support product safety, quality, and regulatory approvalScope to deepen expertise in regulatory frameworks and industry-specific compliance requirementsPotential for progression toward senior or advisory-level regulatory roles, where supported by role facts and organizational needProfessional development opportunities within compliance and regulatory disciplinesCompetitive compensation, benefits package including health coverage, paid time off, retirement planning, and flexible work arrangements where available

About Specialist Staffing Group

Specialist Staffing Group partners with organizations to identify and place talented professionals in regulatory, compliance, risk management, and quality roles. We work closely with industry leaders to understand their compliance challenges and connect them with specialists who can drive regulatory excellence and organizational resilience.