Regulatory Compliance Specialist

Staff Regulatory Compliance Specialist at Johnson & Johnson Med Tech

Location:

Raritan, New Jersey, United States of America

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 the 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 Med Tech. 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.

• 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 gather compliance data, analyze trends, compile compliance updates and share them with Senior leaders within Surgery and Med Tech.
• Implement proactive compliance projects and initiatives, digital reporting improvements and provide compliance support for Quality improvement and remediation activities.
• Refine, report and communicate compliance opportunities through data insights and analytics across J&J Med Tech; 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 times; 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 the site against established internal audit procedures; ensure adequate corrective actions for internal audits, including investigations, corrective action plans, drive timely completion of CAPA plans and perform effectiveness monitoring and closure; where appropriate, execute programs for training and evaluating qualifications of auditors.
• 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.
• Proactively identify and alert management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business; provide internal audit inputs/updates to Quality System Management Reviews for meaningful review.
• Participate in JJRC audits as requested; support the creation and effective deployment of internal J&J Quality System and/or Compliance standards.

• Bachelor’s degree in a Scientific or Technical discipline or equivalent is required; an advanced degree is a plus.
• Minimum of 6 years of proven experience in medical devices, pharmaceuticals or biopharmaceuticals in a Quality, Compliance, Manufacturing or Operations function.
• Knowledge of interpretation and application of 21
  
  CFR 210, 211, 800’s and 600’s, QSR, MDD, MDR and ISO 13485 preferred.
• Current certification of quality system auditor or lead auditor preferred.
• Experience in Data Analysis and reporting preferred; intermediate to advanced Excel data analytics (pivot…