Staff Regulatory Compliance Specialist
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Johnson & Johnson Surgical Vision, Inc., a Johnson & Johnson company, is recruiting for Staff Regulatory Compliance Specialist located in Milpitas, CA.
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.
At Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies, we have a bold ambition: to change the trajectory of eye health around the world. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better and live better. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
The Staff Regulatory Compliance Specialist plans, coordinates, and conducts quality system audits of J&J Vision facilities and supportive activities for compliance as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements. Facilities include worldwide operations, including the United States, Europe, and Asia.
• Provide support to the JJV segment in the performance of audits or audit related activity.
• Provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures.
• Review and monitor required corrective actions; conduct follow-up activities on required action items.
• Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.
• Providing support for FDA, Health Authority and Notified Body inspections conducted at J&J Vision locations, including readiness activities, front- and back-room participation/management and general inspection support as requested. Serve as company representative during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.
• Consult with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls.
• Maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues.
• Develop and maintain key quality and compliance performance metrics. Participate in developing and presenting departmental materials for Management Review and Annual Product Reviews.
• Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to regulated products within the J&J Vision portfolio, including medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.
• Partner with stakeholders and business partners to assess risk and establish proactive risk mitigation strategies and enable innovation in emerging areas.
• Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
• Conducts internal and external QSR/GMP/ISO quality system audits and follow-up activities.
• Assists project teams with identification of quality system requirements to ensure compliance.
• Acts as liaison with external auditors during third party/regulatory audits.
• Monitors regulatory agencies for changes in requirements and evaluates impact to the organization.
• Performs other related duties as assigned by management.
• Bachelor’s degree required in a scientific or engineering discipline (life science, biology, chemistry, engineering, regulatory) or closely related area required.
• RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor preferred.
• Minimum of 4 years of working experience in the quality assurance / compliance audit environment required.
• Minimum of 3 years auditing experience required.
• Strong communication, organizational, negotiation and interpersonal skills required.
• Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments required.
• Understanding and knowledge of a broad set of regulations and standards required (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n°16; CMDR – SOR98-282; Japan MHLW Ordinance No. 169; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, MDSAP, etc.)
• Knowledge of IT internal controls, software development lifecycle (SDLC) methodologies, data integrity requirements, as well as general knowledge of cybersecurity and Medical Device software is preferred.
• Travel: Approximately 10%
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson Surgical Vision, Inc (6234)