Sr. Regulatory Compliance Specialist
"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. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
Sr. Regulatory Compliance Specialist
As a Senior Regulatory Compliance Specialist, your mission, guided by the Regulatory Compliance Manager, is to uphold the highest quality standards in product manufacturing and ensure compliance with relevant regulatory requirements. In this role, you play a vital part in both achieving and maintaining audit readiness while enhancing our Quality Management System.
Tasks & Responsibilities
- Support ensuring the site is audit ready, especially focus on unannounced audit readiness plans. This includes updating audit readiness tools and sharing risks from other Johnson and Johnson locations
- Support the preparation and execution activities for External Audits and Audit Follow up
- Support the execution the Internal Audit program against established internal audit procedures
- Provide input into the Quality & Compliance metrics to ensure these are consistently and accurately collected, and that metrics are captured at the appropriate level for subsequent analysis and reporting
- Use technology to provide innovative and creative solutions for reporting metrics and other compliance data
- Escalate compliance risks in accordance with established procedures
- Support implementation of new standards and regulations
- Apply Credo values in an open and ethical manner and promote Credo values within the Compliance and site teams.
We believe we can make a difference, and we take your career seriously and your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. If you enjoy solving hard problems, you're a self-starter and you're passionate about your career every single day, we'd love to hear from you!
- At a minimum, a Bachelor's degree in one of the following fields is required: Life Sciences, Pharmacy, Engineering, or a related subject with a focus on Quality Regulatory Compliance
- Proficiency in the English language is required. Proficiency in German is highly desirable
- Preferred candidates will demonstrate familiarity with the various regulations and standards relevant to the Medical Device industry.
- Capable of building consensus and leading individuals through change, particularly in the context of regulatory compliance.
- Ability to assess risk when dealing with multiple priorities and prioritize actions to support regulatory compliance.
- Excellent communication skills, with a strong ability to collaborate and influence effectively across different functions, emphasizing the importance of audit readiness.
- Skilled in coaching and supporting individuals to develop a compliance mentality, including conducting robust failure investigations, crafting action plans, and verifying their effectiveness
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.