Regulatory Compliance Specialist jobs in United States
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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Regulatory Compliance Specialist

positionPhiladelphia, PA
timeFull-time
remoteOnsite
senioritySenior Level
date7+ years exp

Kelly Science, Engineering, Technology & Telecom is seeking a Regulatory Compliance Specialist to lead and execute regulatory compliance operations programs across global operations. This role is critical for audit readiness, remediation of compliance issues, and governance development, ensuring compliance with various regulations and standards.

Staffing & Recruiting
Hiring Manager
Arra Patricia Lam
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Responsibilities

Lead and execute regulatory compliance operations programs across global operations
Lead remediation of regulatory compliance issues related to enterprise standards, local procedures, and global regulations (FDA, EU MDR, ISO, MHRA, DSCSA, State Board of Pharmacy)
Serve as a SME on regulatory compliance requirements supporting operations and manufacturing
Drive inspection readiness activities, including training, audit logistics, request management, and daily audit communications
Lead Internal Audit (IA) and External Audit (EA) programs, including planning, execution, reporting, and follow-up
Develop and maintain audit policies, procedures, schedules, playbooks, templates, and metrics
Serve as backroom lead and primary point of contact during regulatory inspections and Notified Body audits (announced and unannounced)
Remediate audit findings and lead CAPA investigations and execution
Design and implement vendor license verification processes and manage third-party regulatory compliance tools and databases
Establish and manage State Board of Pharmacy licensing programs, including applications, renewals, monitoring, and record retention
Develop and implement governance frameworks, policies, procedures, and work instructions to support regulatory compliance
Collaborate with global and regional stakeholders to support strategic initiatives and technology-driven regulatory compliance enhancements
Lead and facilitate global training programs on regulatory compliance topics, including EU MDR, CAPA, inspection readiness, data integrity, and combination products

Qualification

Regulatory compliance expertiseAudit managementFDA regulations knowledgeLead Auditor certificationProject managementStakeholder influencingInspection readinessCommunication skills

Required

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field
7+ years of experience in Regulatory Compliance and Audit Management within a GMP regulated or pharmaceutical environment
In-depth knowledge of FDA regulations, EU MDR, ISO standards, MHRA requirements, and audit processes
Proven experience leading internal and external audits, inspections, and global compliance initiatives

Preferred

Lead Auditor certification
Experience managing DSCSA compliance and State Board of Pharmacy licensing
Experience supporting global organizations and cross-regional stakeholders
Strong project management, communication, and stakeholder-influencing skills

Company

Kelly Science, Engineering, Technology & Telecom

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Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
dateFounded in 1946
location
Troy, Michigan, USA
people-size5001-10000 employees
web-link
https://set.kellyservices.us/

Funding

Current Stage
Late Stage

Leadership Team

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Linda Stuit
Senior Vice President, Engineering Specialty
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Company data provided by crunchbase