Senior Regulatory Compliance Specialist
J&J Family of Companies
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 https://www.jnj.com
**Job Function:**
Legal & Compliance
**Job Sub** **Function:**
Enterprise Compliance
**Job Category:**
Professional
**All Job Posting Locations:**
Norderstedt, Schleswig-Holstein, Germany
**Job Description:**
**Interne Ausschreibung: 21.05.2025-10.06.2025**
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 https://www.jnj.com
Learn more at https://www.jnj.com/medtech
**Sr. Regulatory Compliance Specialist**
**Position overview**
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!
**Qualifications**
+ 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.
Leadership Skills:
+ 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
Por favor confirme su dirección de correo electrónico: Send Email
Todos los trabajos de J&J Family of Companies