Regulatory Affairs Project Manager

Colgate • Piscataway, NJ

5d • $124,000 - $155,000 • Onsite

About The Position

The Regulatory Affairs Project Manager leads the planning, execution, and oversight of complex global regulatory submissions and oversees maintenance of the Medical Device Quality Management System (QMS). The role supports medical device and prescription drug innovation and North American commercialization by ensuring regulatory compliance, improving quality processes, and coordinating cross-functional projects.

The position is based in Piscataway, New Jersey. Relocation assistance is offered within the country.

Requirements

• Bachelor’s degree in Quality Management, Life Sciences, Regulatory Affairs, or a related technical field.
• At least 8 years of experience in regulatory affairs or a related compliance role within the medical device or pharmaceutical industry.
• In-depth technical knowledge of medical device GMP standards, specifically ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• 2 years of project management experience.
• Professional proficiency with electronic Quality Management Systems (eQMS), document management systems (DMS), and advanced project management software such as Smartsheet.
• Proven ability to lead cross-functional teams and clearly communicate complex technical regulatory information to diverse stakeholders.

Nice To Haves

• Master’s degree in Quality Management, Life Sciences, or Regulatory Affairs.
• Professional quality management certification, such as Certified Medical Device Auditor (CMDA) or Certified Quality Auditor.
• Advanced project management training or certification, such as PMP.
• Hands-on familiarity with GreenlightGuru eQMS or a closely related medical device compliance platform.

Responsibilities

• Lead cross-functional projects to prepare, review, and deliver regulatory submissions, including 510(k)s, NDAs, ANDAs, and NDSs, to the FDA and Health Canada on schedule.
• Coordinate QMS projects and ensure system implementations and process improvements comply with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements.
• Identify and monitor project risks and develop mitigation strategies to protect business continuity and minimize timeline impacts or regulatory penalties.
• Manage evolving chemical reporting and environmental compliance data collection requirements, including PFAS, TSCA, DSL, and SmartLabel initiatives.
• Serve as the primary contact for project-related inquiries, provide regular updates to senior leadership, and partner with IT to automate regulatory workflows.
• Lead lessons-learned sessions, update SOPs and work instructions, and train team members on advanced project management methodologies.

Benefits

• Medical, dental, and vision coverage.
• Basic life insurance and disability coverage.
• Paid parental leave.
• 401(k) retirement plan with company matching contributions, subject to eligibility requirements.
• At least 15 vacation/PTO days for salaried employees.
• 13 paid holidays.
• Paid sick leave according to role, location, and applicable local laws.
• Relocation assistance within the country.
• Salaried employees may be eligible for discretionary bonuses and profit-sharing; long-term incentives are available for executive-level roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior