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Principal Regulatory Compliance Specialist

Principal Regulatory Compliance Specialist

J&J Family of CompaniesSan Jose, CA, US
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Principal Regulatory Compliance Specialist

Johnson & Johnson Medical Devices, a member of the Johnson & Johnson Family of Companies, is recruiting for a Principal Regulatory Compliance Specialist. This position will be located in San Jose, California.

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-speciality, end-to-end solutions in orthopaedics, endoluminal intervention and general surgery. This includes the MONARCH platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.

Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact.

This position is expected to provide key oversight and support for Regulatory Compliance and Outreach for the Supply Chain. This position will be a member of the Sector Regulatory Compliance team within the JJRC organization and will work closely with the Business / Franchise and Supply Chain compliance as site compliance. This position will support and enable strong coordination of compliance activities between businesses / franchises, operating companies and sites.

Key Responsibilities :

  • External inspection readiness and associated activities. Lead and manage site audit readiness activities to ensure inspection readiness at all time
  • Prepare and host (as required) external audits : e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site. Responsible for effective regulatory agency inspections.
  • Audit preparation activities (auditor logistics, front room / back room arrangements, identifying / preparing SME's, etc.)
  • Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site.
  • Schedule and manage 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.
  • Provide daily inspection communications regarding potential non-conformities.
  • Review and ensure appropriate responses to any external inspection or other regulatory notification associated with the site.
  • Ensure adequate corrective actions for external audit observations related to the site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure.
  • Execute compliance strategies for New Product Introductions. Support project teams to proactively support new product launches. Attend Design Reviews, provide compliance expertise, visibility to product portfolio and future technologies, external reg trends, PAI readiness, direct DHF assessments and remediation support as needed.
  • Support the integration of acquisitions into the quality system including the audit program, inspection readiness, remediation, health authority / notified body relationship, certifications, and operationalization of new regulations & standards.
  • Provide oversight and compliance review of remediation programs as applicable (MCAP / SDCAP / QEP, etc.).

Internal Audit Program and Management Execution :

  • Establish and execute an effective internal audit schedule for site
  • Execute against established internal audit procedures
  • Ensure quality system is periodically evaluated and audited and appropriate preventive / corrective action is taken to meet the business and regulatory requirements
  • Where appropriate, execute program(s) for training and evaluating qualifications of auditors. Note : Programs can include franchise, supply chain, sector, and / or enterprise elements.

    • Enterprise / Sector Support :

  • Participate in ERC audits as requested.
  • Where appropriate assure representation on all required business unit, sector, and / or enterprise teams
  • Support the creation and effective deployment of internal J&J Quality System and / or Compliance standards.
  • Connect and collaborate with compliance team in other regions
  • Assure that required compliance-related events (e.g., field actions, inspections) are entered into CURVE per required timeframes.
  • Assure that CURVE information is current and updated in a timely manner.

    • Metrics :

  • Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
  • Drive compliance to Quality and Compliance metric targets.
  • Improvement in internal & external audit metrics
  • Create reports and communicate performance against metrics to key stakeholders.
  • Highlight / communicate adverse trends in metrics, and take risk based action to remediate.
  • Escalate items in accordance with established procedures
  • Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.
  • Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image / reputation and / or the business.
  • Proactively assess and influence the external environment by participating on industry and regulatory body work teams. As appropriate collect and provide site input. Communicate outcomes and trends to key stakeholders.
  • Support implementation of new external standards / regulations.
  • Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
  • Provide input into Site Management Reviews (e.g., internal audits.) to allow meaningful review.
  • Proactively communicate organizational and compliance procedure / policy related changes that may impact sites. Ensure feedback and alignment with said changes.
  • Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, and Manufacturing.
  • Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
  • As appropriate, perform annual performance appraisals for identified associates.
  • Establish objectives and development plans for direct reports.
  • Support and promote the safety and environmental objectives of the facility.
  • Responsible for communicating business related issues or opportunities to next management level.
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.

    • Qualifications : Education :

    A minimum of a Bachelors or equivalent University degree is required, Masters or Advanced degree preferred.

    Required :

  • A minimum of 8 years' experience or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities
  • A Bachelor's degree in a related field
  • Lead Auditor or Lead Assessor Certification
  • Knowledge of IT internal controls, software development lifecycle (SDLC) methodologies, and data integrity requirements
  • Knowledge in Software in a Medical Device (SiMD) and other Health software digital products / services
  • Knowledge of Quality System regulations, ISO 13485, cGMP regulations, 21 CFR Part 11, Part 820, MDSAP regulations
  • Ability to make decisions that will effectively support the business and company policies.
  • Required proven leadership, teamwork, initiative, and assertiveness skills.
  • Excellent communication skills, able to quickly build credibility within the Compliance community, executive management, external regulators, and industry.
  • Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.
  • Proven track record of demonstrating collaboration across the organization and at all levels.
  • Balanced technical understanding of products and processes combined with superior business and compliance acumen.
  • Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.
  • Ability to recognize, build support
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