Hiring: Regulatory Affairs Project Manager Company: Colgate-Palmolive Location: Piscataway, NJ Job Posted Time: 2026-09-16 17:03:26 Target Skills & Keywords : Project Management, Risk Management About the job Experience: •2 years of project management experience. •At least 2 years of project management experience. Required Skills: •Regulatory Submission Leadership: Leads cross-functional projects to prepare, review, and deliver complex regulatory submissions (e.g., 510Ks, NDAs, ANDAs, NDS) to the FDA and Health Canada on time. •QMS and GMP Compliance: Coordinates critical Quality Management System projects, ensuring all system implementations and process improvements align strictly with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements. •Risk Management & Lifecycle Monitoring: Proactively identifies and monitors project risks, developing robust mitigation strategies to protect business continuity and minimize timeline impacts or regulatory penalties. •Environmental & Chemical Compliance: Manages evolving cross-category requirements for complex chemical reporting and environmental compliance data collection, including PFAS, TSCA, DSL, and SmartLabel initiatives. •Stakeholder Reporting & Automation: Serves as the primary point of contact for project-related inquiries, presenting regular updates to senior leadership and partnering with IT to automate regulatory workflows. •Continuous Improvement & Training: Heads "lessons learned" sessions and updates documentation standards (SOPs and WIs) while providing targeted training to team members on advanced project management methodologies. Qualifications: •Bachelor’s degree in Quality Management, Life Sciences, Regulatory Affairs, or a related technical field. •At least seven years of experience in regulatory affairs, or a related compliance role within the medical device or pharmaceutical industry, with at least 2 years of project management experience. •In-depth technical knowledge of medical device GMP standards, specifically ISO 13485, ISO 14971, and FDA 21 CFR Part 820. •Direct professional proficiency using electronic Quality Management Systems (eQMS), document management systems (DMS), and advanced Project Management software such as Smartsheet. •Demonstrated success in leading cross-functional teams and communicating complex technical regulatory info clearly to diverse stakeholders. •Master’s degree in Quality Management, Life Sciences, or Regulatory Affairs. •Professional certification in Quality Management, such as a Certified Medical Device Auditor (CMDA) or Certified Quality Auditor. •Advanced training or professional certification in Project Management (such as a PMP certification). •Hands-on familiarity with the GreenlightGuru eQMS system or closely related medical device compliance platforms. Compensation: •$124,000 - $174,000 / year •Competitive benefits and rewards package •Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!