Senior Regulatory Compliance Specialist

Johnson & Johnson; Norderstedt; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading company in healthcare innovation seeks a Senior Regulatory Compliance Specialist in Norderstedt. You will ensure compliance with regulatory requirements, maintain audit readiness, and enhance the Quality Management System. Ideal candidates have a relevant Bachelor's degree and strong communication skills.

Qualifikationen

• Bachelor’s degree with focus on Quality Regulatory Compliance required.
• Proficiency in English required; German highly desirable.
• Familiarity with Medical Device regulations preferred.

Aufgaben

• Ensure site is audit ready and support external audits.
• Develop Quality & Compliance metrics and analyze data.
• Assist in implementing new standards and regulations.

Kenntnisse

Risk assessment

Communication

Collaboration

Coaching

Ausbildung

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field

Jobbeschreibung

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 Details

Job Function: Legal & Compliance

Job Sub Function: Enterprise Compliance

Job Category: Professional

Location: Norderstedt, Schleswig-Holstein, Germany

Job Description

Interne Ausschreibung: 21.05.2025 - 10.06.2025

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

Responsibilities

1. Support ensuring the site is audit ready, especially focusing on unannounced audit readiness plans, updating audit readiness tools, and sharing risks from other Johnson & Johnson locations.
2. Assist in the preparation and execution of External Audits and follow-up activities.
3. Support the implementation of the Internal Audit program according to established procedures.
4. Contribute to the development of Quality & Compliance metrics, ensuring accurate data collection and analysis.
5. Leverage technology to report metrics and compliance data innovatively.
6. Escalate compliance risks following established procedures.
7. Assist in implementing new standards and regulations.
8. Promote Credo values ethically within the Compliance and site teams.

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 is highly desirable.
• Familiarity with regulations and standards relevant to the Medical Device industry is preferred.

Leadership Skills

• Ability to build consensus and lead change in regulatory compliance contexts.
• Risk assessment skills for managing multiple priorities supporting compliance.
• Excellent communication, collaboration, and influence skills across functions, especially regarding audit readiness.
• Coaching skills to develop a compliance mindset, including conducting failure investigations, creating action plans, and verifying their effectiveness.