Senior Regulatory 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 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.

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. You play a vital role in achieving and maintaining audit readiness while enhancing our Quality Management System.

Tasks & Responsibilities

1. Support ensuring the site is audit ready, especially focusing on unannounced audit readiness plans. This includes updating audit readiness tools and sharing risks from other Johnson & Johnson locations.
2. Support the preparation and execution of External Audits and follow-up activities.
3. Support the execution of the Internal Audit program according to established procedures.
4. Provide input into Quality & Compliance metrics to ensure they are consistently and accurately collected, and metrics are captured at the appropriate level for analysis and reporting.
5. Use technology to provide innovative solutions for reporting metrics and compliance data.
6. Escalate compliance risks following established procedures.
7. Support the implementation of new standards and regulations.
8. Apply Credo values ethically and promote them within Compliance and site teams. We value your career development, offering e-university, on-the-job training, and various projects to support your growth. If you enjoy solving complex problems, are a self-starter, and passionate about your career, we would love to hear from you!

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field with a focus on Quality Regulatory Compliance.
• Proficiency in English is required; German proficiency is highly desirable.
• Familiarity with regulations and standards relevant to the Medical Device industry is preferred.
• Leadership skills include building consensus, leading through change, assessing risks, and prioritizing actions for compliance.
• Excellent communication skills, with the ability to collaborate and influence across functions, emphasizing audit readiness.
• Skilled in coaching and supporting teams to develop a compliance mindset, including conducting failure investigations, creating action plans, and verifying their effectiveness.