Senior Manager, Regulatory Compliance

Robotics & Digital Solutions, part of Johnson & Johnson of companies, is recruiting for a Senior Manager, Regulatory Compliance to be located in Redwood City and/or Santa Clara, CA! Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon 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 robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com. The Senior Manager, Regulatory Compalince is responsible for establishing and maintaining a robust Compliance Program for the site in-order to ensure compliance to local, national, and international regulatory requirements, company policies and procedures and J&J Corporate requirements. The site is in Northern California. The Senior Manager, Regulatory Compliance will be a member of the J&J Regulatory Compliance team and will work with site leads and Quality Operations leads of the sites within the region and with the Regulatory Compliance teams of other regions and business groups. The Senior Manager, Regulatory Compliance is expected to collaborate with other groups within the J&J Regulatory Compliance (JJRC) organization to support execution of independent audits and special assessments and deploy compliance initiatives. The Senior Manager, Regulatory Compliance is responsible to partner with the site for the deployment of applicable J&J Quality System Standards. This position ensures effective business wide compliance program that meets requirements for medical device (MD products) and combination product business. This position will partner with Compliance leaders globally to ensure audit readiness and overall compliance. This individual will collaborate with all levels building strategic partnerships to further the company in the refinement of strategic direction for short and long-term compliance objectives. Sr. Manager Regulatory Compliance will be responsible for the execution of compliance activities, to ensure a sustainable state of compliance to applicable regulations, standards and internal policies and procedures. This individual will be responsible for Compliance data gathering, analysis, reporting and communicating the output of the data analysis, trends and conclusions to Senior Management. This individual will be responsible for supporting the development of the compliance strategies and execution of such strategies, the implementation of proactive compliance projects and Initiatives, Internal Audit program, as well as providing compliance guidance, including compliance support for Quality improvement and remediation activities. Serves on cross site and cross segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements. This position will partner with Compliance leaders globally to ensure robust internal audit program is implemented. This individual will collaborate with all levels building strategic partnerships for refinement of strategic direction for short and long-term compliance objectives both within the site and across the Medical Device (MD) segment. 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 have the following responsibilities: Compliance Program Establish and maintain a robust Compliance program for the site to ensure compliance to local, national and international regulatory requirements, company policies and procedures, and J&J Corporate requirements. Partner with the Compliance teams of other business groups to support execution of internal audit schedules. Ensure establishment of standardized Internal Audit Program, schedule. Ensure qualified personnel, including knowledge, experience, and independence, performs internal audits. Collaborate with other groups in the JJRC organization to support execution of independent audits and special assessments and deploy compliance initiatives. Establish and maintain external audit/regulatory inspection readiness plans at the site in preparation for any external audit/ inspection. Supports external audits/ inspections of the sites as required. Partner with the appropriate Leadership and Compliance teams on the formulation of responses to external audit observations related to the sites within the business groups. Collaborate with business partners in the identification and implementation of corrections, corrective and preventive actions. Ensure effective and timely completion of all actions. Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards. Ensure results of monitoring process are routinely communicated to management through the Management Review process. Alert management of quality and compliance issues for proper and timely escalation and resolution. Assure all external auditing companies meet internal requirements prior to executing any portions of the contracting agreement. Serve as a subject matter expert, as needed, to support proactive or reactive responses to issues. Provide leadership, oversight and strategic guidance from the site perspective for significant regulatory compliance issues in the manufacturing sites, EMs and suppliers. Oversight may include independent monitoring and reporting. Standardize and leverage Regulatory Compliance policies, practices, metrics and resources across the site. Ensure timely and accurate reporting and publishing of internal and external audit metrics for the sites within the site. Provide update to management on the classification of all External Audits (i.e. Regulatory Agency/Health Authority inspections, Notified Body audits) and observations at all the sites. Coordinate compliance training as required. Monitor CURVE Database for Field Action, Regulatory Inspection and QScan data accuracy and completeness. Supervise compliance personnel according to Human Resources policies and procedures, including hiring, training, and mid/end-year performance appraisals. Provide leadership and development to all direct reports assuring active participation in performance management, succession planning and talent development activities. Ensure all direct reports comply with Environmental, Health and Safety requirements. Manage compliance budget for the site. Regulatory Intelligence Support an MD framework and network of subject matter experts providing input to, appropriately influence, and interpret requirements of, Regulatory Agencies around the globe regarding regulations, regulatory pathways, or approaches. Work with other Compliance teams to identify, prioritize and ensure implementation of new and revised regulatory requirements and expectations. Support implementation plans for regulatory changes including routinely monitoring and verification of implementation activities at the site. Other Responsibilities Support Quality and Compliance Strategies. Provide support and guidance to key individuals and teams to assure compliance. Ensure alerting, reporting and escalation of Quality and Compliance issues to the appropriate Leadership and Compliance teams. Perform other work-related duties as assigned by the Director, Regulatory Compliance. Responsible for communicating business related issues or opportunities to next management level 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 Required A minimum of a University/Bachelor's Degree in Scientific or Technical discipline or equivalent A minimum of 10 years of related experience is required, with a minimum of 8 years in a Quality function. Quality experience in Medical Device or Pharmaceutical or Biopharmaceutical products industries Direct experience with FDA or ISO inspections in a leadership role Experience managing others in a direct and matrixed environment Proven success in Compliance and reputation, large-scale QMS experience Change management and project management experience Strong executive presentation skills Issue remediation experience Strong analytical skills and experience implementing risk-based oversight programs across multiple sites or corporate experience Expertise on the new Quality System Regulations, with the ability to relate these real live issues. Proven ability to initiate and implement Quality System changes Knowledge of quality and manufacturing systems & processes and applicable regulations, (ISO 13485, MDD 93/42/EEC and amendments, MDR, ISO 14971, FDA’s GMP and QSR requirements for medical devices, 21CFR part 11, 820, 803, 806, 807, Part 4, Therapeutic Goods (Medical devices) Regulations, ANVISA GMP regulations, CMDR SOR 98-282, Japan MHLW Ordinance No.169 and other applicable regulations, standards) Experience in Data Analysis and reporting This position will be located in Redwood City and/or Santa Clara, CA and may require up to 25% domestic & international travel Preferred Other Advanced degree Lead Auditor Certification / Certified Quality Auditor (CQA) Knowledge of interpretation and application of 21CFR 800's, QSR, MDD, MDR and ISO 13485:2016 / MDSAP Project management skills preferred At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law Primary Location United States-California-Redwood City-150 Shoreline Dr Other Locations United States-California-Santa Clara Organization Auris Health, Inc. (6267) Job Function Quality Requisition ID 2206040289W