Director Technology Regulatory Compliance
- Bridgewater, NJ
Johnson & Johnson Services Inc. is recruiting for a Director of Technology Regulatory Compliance located in Raritan, New Jersey.
Caring for the world, one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 275 operating companies in more than 60 countries, with more than 128,700 employees. Our worldwide headquarters is located in New Brunswick, New Jersey, USA.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
This role is responsible for leadership, execution and continuous improvement of GxP Compliance programs, including continued and timely compliance with new or changing regulatory requirements and verification of internal and supplier audit corrective actions. The role owns health authority inspection readiness for J&J Technology Services and is central in supporting global business units during external inspections as it relates to computer system validation and other technology related questions.
The role provides compliance subject matter expertise across a broad range of technical areas, including the rapidly growing areas of digital health and software as a medical device, to ensure requirements are embedded into innovation initiatives by design.
This role collaborates with Technology Services, Technology Quality, and across business sectors to assure computer systems and other technologies meet J&J Quality Standards; drives continuous improvement and efficiency; and engages with industry groups to shape emerging regulations impacting technology. The role interprets current and emerging regulations at a global level, assesses and communicates trends to senior leaders, and recommends solutions for efficient risk management.
• Leads and develops team to support the rapid pace of technical innovation.
• Continuously improves compliance program efficiency and makes senior leaders aware of critical issues/risks.
• Crafts compliance strategies and position papers to enable innovation in emerging areas, such as SaMD and artificial intelligence.
• Analyzes data to identifies trends and insights to drive proactive quality.
• Monitors and interprets new/changing regulatory expectations and partners to conduct gap assessments of the Quality Management System and/or operational processes.
• Classifies the risk of audit observations, supports the development of remediation plans, and verifies execution of corrective actions.
• Owns inspection readiness program and engages directly with regulatory agencies.
• Builds and delivers regulatory compliance training and awareness programs.
Required Experience and Skills:
• Bachelors degree is required. Degree concentration in IT, engineering, science, business or QRC is preferred. MBA or MS is preferred.
• Minimum 10 years in Quality and Regulatory Compliance in a regulated healthcare environment.
• Deep expertise in global medical device regulations, requirements and standards (e.g., CFRs, ISO, cGMP), including Annex 11, Part 11 and other global equivalents and how these apply to technology and software.
• Detailed understanding of cGxP Risk Management and data integrity principles.
• Experience with Health Authority and Notified Body inspections (i.e FDA, MHRA, TGA), including directly engaging with regulators.
• Understanding of IT concepts and practices, i.e., SDLC, and Cybersecurity, as well as knowledge of medical device software quality.
• Previous people leadership (direct reports) required.
• Ability to research, analyze, and interpret regulations and resolve complex compliance issues.
• Ability to develop strategy, build consensus, and inspire teams to drive outcomes, even under ambiguous circumstances.
• Ability to influence, negotiate, and build positive relationships with internal and external partners.
• Excellent written and verbal communication skills. Able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written & oral forms.
• Will require approximately 10% domestic and international travel, with the need to attend occasional phone/virtual meetings outside of core business hours.
Preferred Experience and Skills:
• Pharmaceutical compliance (ICH, PIC/S) experience preferred
• Regulatory affairs experience, including understanding of 510K and PMA submission process (or global equivalent).
• CISA, ISO Lead Auditor, and/or ASQ CQA certifications and trainings are preferred
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.
United States-New Jersey-Raritan-
Johnson & Johnson Services Inc. (6090)
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