Staff Compliance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 and support activities for compliance to federal, international regulations, standards (e.g., FDA QSR, FDA cGMP, ISO, etc.) and Company requirements.  The Staff Regulatory Compliance Specialist is also responsible for 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. 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 activities.

• →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.
• →Provide regulatory assessments of internal/external audit findings.  Review/monitor correction, corrective, preventive, and effectiveness actions.
• →Promote a culture of proactive compliance to regulations, standards, and procedures and risk management throughout the organization.
• →Develop and maintain key quality and compliance performance metrics. Participate in developing and presenting departmental materials for Management Review and other leadership forums.
• →Perform other related duties as assigned by management.

• Bachelor’s degree required in a scientific or engineering discipline or equivalent related experience (ASQ - CQA, CQE or SCQE, ISO Lead Assessor, RAC certification).

• Qualified Quality Lead Assessor and experienced auditor in a Quality regulated environment.

• Minimum of 6 years of working experience in the quality assurance / compliance audit environment.

• Strong knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments. Experience in managing and implementing robust Corrective and Preventive Action Systems.

• Experience managing External Regulatory/Notified Body Inspections (e.g. FDA, ANVISA, PMDA, BSI, etc.)
• Strong communication, organizational, negotiation and interpersonal skills required.  Ability to work cross-functionally and influence change.
• Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; ISO 13485; EU MDD/MDR; MDSAP, etc.)

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.