Manager, Technology Regulatory Compliance

Johnson & Johnson Innovative Medicine•West Chester, PA

2d•$102,000 - $177,100•Hybrid

About The Position

The Manager, Technology Regulatory Compliance, is responsible for leading compliance activities related to technical and regulatory requirements across the organization in support of product and non-products systems. This role ensures that technical processes, documentation, and system implementations align with applicable regulatory standards, quality system requirements, and internal policies. The position plays a critical role in managing compliance risk, conducting audits and assessments, supporting audit and inspection readiness, and enabling compliant execution of technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, and IT teams.

Requirements

Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or related discipline is 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 processes.
Experience supporting audits, inspections, and compliance assessments.
Ability to manage complex technical compliance topics across cross‑functional stakeholder groups.
English is required.

Nice To Haves

Advanced degree in a scientific, regulatory, or technical field is preferred.
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with EMEA regulatory and technical compliance frameworks.
Experience working in a global or matrixed organization.
Exposure to regulatory inspections involving technical or system compliance.
Quality or Regulatory certifications (e.g., RAC, ASQ).
Strong analytical, risk‑management, and problem‑solving skills.
Effective written and verbal communication skills.
Quality or Regulatory certifications are preferred.

Responsibilities

Lead and manage technology regulatory compliance activities, ensuring adherence to regulatory and quality system requirements.
Provide compliance oversight for technology processes, systems, and documentation supporting regulated activities.
Interpret regulatory and technology standards and translate them into actionable compliance requirements.
Partner with Quality, Regulatory Affairs, Engineering, and IT teams to support compliant systems and process implementation.
Conduct internal audits, external audits, and support health authority inspections in support of product and non-product technology regulatory compliance.
Monitor compliance risks, trends, and performance metrics; drive corrective and preventive actions.
Ensure consistent application of global and regional compliance policies, procedures, and controls.
Drive continuous improvement initiatives to strengthen technical compliance, governance, and effectiveness.

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year