Job Function: Quality
Job Sub Function: Quality & Compliance Audit
Job Category:Professional
All Job Posting Locations:Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America
Job Description:About MedTechFueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
We are searching for the best talent for Manager, Technology Regulatory Compliance.This is a hybrid role available within United States. While specific states and cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
- Raynham, MA
- West Chester, PA
- Palm Beach Gardens, FL
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.
Key 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.
Qualifications Education: - Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or related discipline is required.
- Advanced degree in a scientific, regulatory, or technical field is preferred.
Experience and SkillsRequired: - 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.
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.
Other: - Language: English is required.
- This position may require domestic and/or international travel.
- Certifications: Quality or Regulatory certifications are preferred.
Required Skills:Preferred Skills:Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Process Improvements, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Risk Management, Technical Credibility, Third-Party Auditing
The anticipated base pay range for this position is :$102,000.00 - $177,100.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
