Manager, Technical Regulatory Compliance
Job Location:
West Chester, OH - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality & Compliance AuditJob Category:
ProfessionalAll Job Posting Locations:
Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America West Chester Pennsylvania United States of AmericaJob Description:
DePuy Synthes is recruiting for a Manager Technical Regulatory Compliancelocatedin Raynham MA or Palm Beach Gardens FL or West Chester PA.
Job Overview
The Manager Technical RegulatoryComplianceis responsible forleading compliance activities related to technical system and process regulatory requirements. This role ensures that technical operations systems and documentationcomply withapplicable regulations 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 technical initiatives by partnering closely with Quality Regulatory Affairs Engineering Manufacturing and IT teams.
Key Responsibilities
Lead and manage technical regulatory compliance activities in alignment with global and regional compliance strategies.
Provide compliance oversight for technical processes systems and documentation supporting regulated activities.
Interpret regulatory and technical standards and translate them into actionable compliance requirements.
Partner with Quality Regulatory Affairs Engineering Manufacturing and IT teams to support compliantsystemand process implementation.
Support internal audits external audits and health authority inspections related to technical compliance.
Monitor compliance risks trends and performance metrics and drive corrective and preventive actions.
Ensure consistent application of global and sitespecific compliance policies procedures and controls.
Drive continuous improvement initiatives to strengthen technicalcompliancegovernance and effectiveness.
Qualifications
Education:
Bachelors degree in Regulatory Affairs Quality Engineering Life Sciences Information Systems ora relateddiscipline (required).
Advanced degree in a scientific regulatory or technical field (preferred).
Experience and Skills:
:
Typically6-8years of progressive experience in Regulatory Compliance Quality Systems Engineering or related roles within a regulated industry.
Strong working knowledge of regulatory and technical requirementsimpactingquality systems and manufacturing processes.
Experience supporting audits inspections and regulatory assessments.
Ability to manage complex technical compliance topics across crossfunctional stakeholder groups.
Strong analytical riskmanagement and problemsolving skills.
Effective written and verbal communication skills.
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 regulatory inspections involving technical or system compliance.
Quality or Regulatory certifications (e.g. RAC ASQ).
Other:
Language: English.
Travel: Limited; occasional domestic travel.
Certifications: Quality or Regulatory certifications preferred but not.
For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.
Johnson & Johnson announced plans to separate our Orthopaedics 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 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.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
Required Skills:
Preferred Skills:
Agile Internal Audit Analytical Reasoning Audit and Compliance Trends Compliance Frameworks Compliance Management Compliance Policies Compliance Risk Controls Compliance Critical Thinking Developing Others Inclusive Leadership Leadership Problem Solving Quality Auditing Quality Control (QC) Quality Standards Regulatory Compliance Regulatory Environment Risk Management Supervision Third-Party AuditingThe anticipated base pay range for this position is :
$102000.00 - $177100.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Companys long-term incentive program.
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: - Experience:
Manager
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
