Compliance Lead, US RMPV Compliance (Titusville, NJ)

Job Summary

J&J Family of Companies is seeking a Compliance Lead for US RMPV Compliance in Titusville, Mercer County, NJ. This senior role oversees regulatory compliance programs, ensuring all products meet FDA and international standards.

Key Responsibilities

• Develop, implement, and maintain the US RMPV (Risk Management and Post‑Market Vigilance) compliance framework.
• Lead cross‑functional teams to conduct risk assessments, audits, and corrective action plans.
• Monitor changes in FDA, EMA, and other regulatory requirements and translate them into actionable policies.
• Prepare and submit compliance documentation, including reports, filings, and post‑market surveillance data.
• Provide training and guidance to internal stakeholders on compliance best practices.
• Collaborate with legal, quality, and product development teams to ensure alignment with corporate compliance strategy.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field (advanced degree preferred).
• Minimum 7 years of experience in regulatory compliance, risk management, or post‑market surveillance within the medical device or pharmaceutical industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and global post‑market reporting requirements.
• Excellent analytical, communication, and leadership skills.

Compensation

Salary: $109,738.34 per year.

Location

Titusville, Mercer County, New Jersey, United States.

Frequently Asked Questions

What does a Compliance Lead at J&J do?

The Compliance Lead oversees the US Risk Management and Post‑Market Vigilance program, ensuring products meet FDA and global regulatory standards.

What qualifications are required for this role?

A bachelor’s degree in a relevant field, at least 7 years of regulatory compliance experience in medical devices or pharma, and strong knowledge of FDA and ISO requirements.

Where is the position located?

The role is based in Titusville, Mercer County, New Jersey, USA.