Regulatory Affairs Project Manager

As the Regulatory Affairs Project Manager, you will lead the planning, execution, and oversight of complex global regulatory submissions and ensure the rigorous maintenance of our Medical Device Quality Management System (QMS). This critical leadership role directly supports rapid portfolio growth, focusing on medical device and Rx drug innovation to meet the company’s 2030 objectives. By driving continuous improvement in quality processes and partnering with cross-functional teams, you will safeguard compliance while accelerating commercialization timelines for North America. This position offers an exciting opportunity to spearhead high-impact projects that shape the future of our professional clinical portfolio.

Responsibilities

• 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.

Required 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.

• Proven track record of leading cross-functional teams and communicating complex technical regulatory info clearly to diverse stakeholders.

Preferred Qualifications

• 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.