"Alerted.org

Regulatory Compliance- Operations & Manufacturing

Regulatory & Quality Compliance

+ 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 Subject Matter Expert (SME) on regulatory compliance requirements supporting operations and manufacturing.

Audit & Inspection Readiness

+ 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.

Program & Process Development

+ Design and implement vendor license verification processes and manage third-party 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.

+ Create practical system and process solutions to address complex regulatory and operational challenges.

Cross-Functional Leadership & Training

+ Collaborate with global and regional stakeholders to support strategic initiatives and technology-driven compliance enhancements.

+ Lead and facilitate global training programs on regulatory compliance topics, including EU MDR, CAPA, inspection readiness, data integrity, and combination products.

Required

+ Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field (or equivalent experience).

+ 7+ years of experience in Regulatory Compliance and Audit Management within medical device, pharmaceutical, or regulated healthcare industries.

+ 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 or equivalent training.

+ 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.

Key Competencies

+ Regulatory compliance expertise and audit leadership

+ Inspection readiness and CAPA management

+ Auditing manufacturing environment where operations are occurring

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.