Staff Regulatory Compliance Specialist

Biosense Webster, Inc. is recruiting for a Staff Regulatory Compliance Specialist, located in Irvine, CA. At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes. Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day. Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn. The Staff Regulatory Compliance Specialist will maintain robust compliance programs for the Biosense Webster Inc. business in the United States, ensuring compliance with all applicable regulatory requirements, company procedures, and J&J Corporate policies. The Staff Regulatory Compliance Specialist will partner with Quality, Research & Development, Regulatory Affairs, Supply Chain, Clinical Research and Johnson & Johnson Regulatory Compliance to identify and mitigate quality and compliance risks and ensure a strong regulatory compliance profile for the assigned sites. Maintain the internal audit program and external inspection/audit readiness. Support the integration of new acquisitions, due diligence, new product introductions from the regulatory compliance perspective. Support the development and execution of remediation programs as needed. Key Responsibilities: Under limited supervision, with general direction and in accordance with all applicable regulatory requirements, company procedures, and Johnson & Johnson Corporate policies, this position: Maintains the internal audit program that ensures quality management systems are operating in compliance; develops and manages audit plans; conducts audits, develops metrics, and compiles data on auditing results, issues, trends, and corrective actions and presents to senior management; and develops and delivers required training. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements. Ensures compliance to regulations, standards, and internal policies. Responsible for implementing compliance strategies aligned with the MT Q&C and JJRC strategies. Supports processes, organizations, and governance to assure that compliance related requirements and goals for the MT Sites under responsibility are achieved. Partners with stakeholders (e.g., Source Quality, Source, Franchise Quality, Quality Systems, Manufacturing, and other business functions) for the identification of quality and regulatory compliance risks and the development of mitigation plans. Communicates quality and regulatory compliance related risks or opportunities to appropriate management level. Supports the integration of acquisitions into the quality system including deployment of the audit program, external inspection/audit readiness, remediation, health authority/notified body relationship, certification, and operationalization of new regulations & standards. Provides support for the development and deployment of remediation programs (MCAP/SDCAP/QEP, PAM, etc.). Provides periodic data and analytics to business partners, including regulatory compliance data and current global health authority trends that enable the organization to deliver on quality and regulatory compliance commitments. Supports proactive approach to address regulatory trends. Provides support and regulatory compliance advice for new product introductions, acquisitions and divestitures, and other business growth initiatives as needed. Supports strategic Regulatory Compliance initiatives and projects Qualifications Education: 4-year college degree (Bachelor’s Degree) or equivalent in Engineering, Technical or Science-related field Experience and Skills: Required: At least 5 years of experience in a Quality, Manufacturing or Engineering function in medical device industry Experience supporting Health Authority inspections, Notified Body audits and internal audit program Working knowledge of medical device regulations and standards: 21 CFR Part 820 QSR, ISO 13485, Brazil GMP, Canada Medical Devices Regulations SOR 98-282, Japan’s MHLW MO 169, EU MDR Strong written and oral communication skills as well as report writing, presentation and training skills Proven leadership, teamwork, collaboration, and influencing skills to drive the right actions and enable adoption of best practices Capability to interpret regulatory requirements in the light of current trends and business application Ability to accomplish objectives in a timely manner with limited or without day-to-day supervision. Good interpersonal skills; customer oriented Demonstrated initiative and assertiveness Strong problem solving and root cause analysis skills Look for pragmatic solutions that balance risk/benefit for both short- and long-term success Be open to diverse opinions and ideas. Active listening Strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint) Preferred: Lead Auditor certification from an accredited / recognized organization Project management experience Certifications: Green Belt/Process Excellence, CMMI Lead Assessor, or other Quality Certifications Supervisor experience, talent development Other: Requires between 20-30 % of domestic (US) travel Interacts with Health Authorities, Notified Bodies, and other regulatory organizations, as applicable Interacts with internal and external functions from different levels and includes the hosting of business meetings with different management levels. Ability to work in a stressful/fast paced and ambiguous environment 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 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. Primary Location United States-California-Irvine-31 Technology Dr Organization Biosense Webster Inc. (6010) Job Function Regulatory Affairs Requisition ID 2206086931W