Senior Regulatory Compliance Specialist

Nur für registrierte Mitglieder

Norderstedt

EUR 60.000 - 80.000

Jobbeschreibung

Join to apply for the Senior Regulatory Compliance Specialist role at Johnson & Johnson MedTech

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Join to apply for the Senior Regulatory Compliance Specialist role at Johnson & Johnson MedTech

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

Learn more at https://www.jnj.com/medtech

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 of 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.
Familiarity with the regulations and standards relevant to the Medical Device industry is preferred.

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.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Legal

Industries

Hospitals and Health Care