Manager, Integration, Depl. Sys. & Dev
Job Location:
Raynham, MA - 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:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Raynham Massachusetts United States of AmericaJob Description:
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.DePuy Synthes is recruiting for a(n) Manager IntegrationDepl. Sys. & Dev Regulatory OtherlocatedinRaynham Massachusetts West Chester PA Warsaw IN Palm Beach Gardens FLor NJ.
The Manager Integration Deployment Systems & Developmentis responsible forleading regulatoryrelated system integration deployment and development activities that support compliant business operations. This role plays a critical part in ensuring regulatoryprocessesdata and tools are effectively integrated deployed andmaintainedto meet evolving regulatory requirements. The position partners closely with Regulatory Affairs Quality IT and business stakeholders to enable scalablecompliant and efficient regulatory systems and solutions across the organization.
Key Responsibilities
Lead and manage regulatory system integration deployment and development initiatives in alignment with regulatory and compliance requirements.
Partner with Regulatory Affairs Quality IT and business teams to define system requirements and ensure compliant implementation.
Support deployment and ongoing enhancement of regulatory systems and tools ensuring data integrity and usability.
Oversee change management activities related to regulatory system updates integrations and enhancements.
Ensure regulatory system processes align with internal policies quality system requirements and applicable regulations.
Support audits inspections and assessments related to regulatory systems and data.
Monitor regulatory and systemrelated changes and assess impactstotools processes and integrations.
Drive continuous improvement initiatives to enhance regulatory system efficiency scalability and compliance.
Qualifications
Education:
Bachelors degree in Regulatory Affairs Information Systems Engineering Life Sciences ora relateddiscipline (required).
Advanced degree or professional certification in Regulatory Affairs Information Systems or related fields (preferred).
Experience and Skills:
Required:
Typically6-8 years of progressive experience in regulatory systems regulatory operations IT systems integration or a related role within a regulated industry.
Experience supporting system integration deployment or development initiatives in a compliancedriven environment.
Strong understanding of regulatory processes and data requirements.
Ability to translate regulatory and business requirements into system solutions.
Preferred:
Experience in medical devices healthcare or other highly regulated industries.
Familiarity with regulatory information management (RIM) systems or related platforms.
Experience supporting audits or inspections involving regulatory systems.
Experience working in a global or matrixed organization.
Demonstrated experience driving system or process improvement initiatives.
Effective written and verbal communication skills.
Strong project management problemsolving and stakeholder management skills.
Other:
Language: English.
Travel: Limited; occasional domestic or international travel as needed.
Certifications: Regulatory Affairs Certification (RAC) or relevant systems/project 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 ourOrthopaedicsbusiness toestablisha standaloneorthopaedicscompanyoperatingas DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be regulatory approvals and other customary conditions and approvals. Should you accept this position it isanticipatedthat following conclusion of the transaction you would be an employee of DePuySynthesand 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 atan appropriate timeand subject to any necessary consultation processes.
Johnson & Johnsonisan 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 federalstateor local law. We actively seek qualified candidates who areprotectedveterans 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 requestan accommodation external applicants please contact us via internal employees contactAskGSto be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
Required Skills:
Preferred Skills:
Analytical Reasoning Business Writing Coaching Compliance Risk Fact-Based Decision Making Industry Analysis Legal Support Process Improvements Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Strategic Thinking Technical CredibilityThe anticipated base pay range for this position is :
$117000.00 - $201250.00Additional 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
