Staff Regulatory Compliance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality & Compliance Audit

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Fueled 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

We are searching for the best talent for a Staff Regulatory Compliance Specialist to be located in Raritan, NJ.

Purpose: The position of the Staff Regulatory Compliance Specialist is responsible for establishing and maintaining robust Compliance Programs at Ethicon Raritan HQ site and will be supporting the other Ethicon sites as needed in order to ensure compliance to local, national and international regulatory requirements, applicable standards, company policies and procedures and J&J corporate requirements. This individual will be responsible for the implementation of proactive compliance projects and Initiatives, conducting Internal audits as part of site Internal Audit program, leading Inspection Readiness activities and supporting external audits, supporting execution of independent audits and special assessments, digital improvements as well as providing compliance support for Quality improvement and remediation activities.  This individual will also be responsible for Compliance data gathering, data analysis, trending and compiling compliance updates and sharing the same with Senior leaders within Surgery and MedTech. The Staff Regulatory Compliance Specialist will be a member of the Ethicon and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated Ethicon sites and with the Regulatory Compliance teams of other regions and business groups.

Responsibilities:

• Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:

• This individual will be responsible for Compliance data gathering, data analysis, trending and compiling compliance updates and sharing with Senior leaders within Surgery and MedTech. This individual will also be responsible for the implementation of proactive compliance projects and Initiatives, digital reporting improvements as well as providing compliance support for Quality improvement and remediation activities.

• Refine, report and communicate compliance opportunities through data insights and analytics across J&J MedTech. Evaluate, Ideate and implement  new digital  reporting processes Manage reporting process improvements

• Lead and manage site inspection readiness activities to ensure inspection readiness at all time. Schedule and handle mock inspections as part of External Inspection Readiness activities. Provide timely information to support the inspection process, including those that may be taking place at other sites / locations.

• Establish and implement an effective internal audit schedule for site against established internal audit procedures. Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive timely completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure. Where appropriate, execute program(s) for training and evaluating qualifications of auditors. Note: Programs can include franchise, supply chain, sector, and/or enterprise elements.

• Drive compliance audit metrics and provide required support to ensure they are on track. Create reports and communicate performance against metrics to cross-functional groups. Highlight/communicate adverse trends in metrics and take risk-based action to remediate. Support Field Action assessments.

• Responsible for the proactive identification and alerting of management