Sr. Manager, Technical Regulatory Compliance

Johnson & Johnson Innovative Medicine • West Chester, PA

18h • $122,000 - $212,750 • Hybrid

About The Position

The Sr. Manager, Technical Regulatory Compliance provides senior leadership for regulatory compliance related to technical systems, processes, and documentation. This role ensures that technical and operational activities comply with applicable regulatory requirements, quality system standards, and internal policies. The position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of complex technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams.

Requirements

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or a related discipline (required).
• Typically 6-8 years of progressive experience in Regulatory Compliance, Quality Systems, Engineering, or related roles within a regulated industry.
• Strong working knowledge of regulatory and technical requirements impacting quality systems and manufacturing processes.
• Demonstrated experience leading audits, inspections, and regulatory assessments.
• Proven ability to manage complex technical compliance topics across cross‑functional stakeholder groups.
• English required.

Nice To Haves

• Advanced degree in a scientific, regulatory, or technical field (preferred).
• Experience in medical devices, healthcare, or other highly regulated industries.
• Familiarity with U.S. regulatory and technical compliance frameworks.
• Experience working in a global or matrixed organization.
• Exposure to computerized system validation (CSV) or data integrity programs.
• Quality or Regulatory certifications (e.g., RAC, ASQ).
• Strong analytical, risk‑management, and problem‑solving skills.
• Effective written and verbal communication skills with senior stakeholders.
• Quality or Regulatory certifications preferred but not required.

Responsibilities

• Lead and oversee technical regulatory compliance activities in alignment with global and regional compliance strategies.
• Provide compliance oversight for technical processes, computerized systems, and documentation supporting regulated activities.
• Interpret regulatory and technical standards and translate them into actionable compliance requirements and controls.
• Partner with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams to ensure compliant system implementation and change management.
• Lead audit and inspection readiness related to technical compliance, including internal audits and health authority inspections.
• Monitor compliance risks, trends, and performance metrics and drive corrective and preventive actions.
• Ensure consistent application of global and site‑specific compliance policies, procedures, and controls.
• Drive continuous improvement initiatives to strengthen technical compliance governance, efficiency, and effectiveness.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

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