Senior Regulatory Specialist (m/f/d) - IVD

TN Germany; Stuttgart; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in the life sciences sector is seeking a Senior Regulatory Specialist to join their Global Regulatory Affairs team. This role involves supporting new product launches, managing regulatory submissions, and ensuring compliance with international standards. The position can be based in Germany or anywhere in Europe, offering a hybrid work model.

Leistungen

Comprehensive global benefits

Private healthcare

Pensions

Stock plans

Insurance

Professional growth opportunities

Diversity and inclusion initiatives

Work-life balance

Permanent contract

Qualifikationen

• Several years of relevant experience in a regulated environment.
• Knowledge of international registration processes.

Aufgaben

• Coordinate international submissions and manage product change notifications.
• Ensure compliance with global regulatory and quality standards.
• Lead regulatory projects and consult with regulatory agencies.

Kenntnisse

Teamwork

Leadership

Communication

Ausbildung

Bachelor’s degree in Regulatory Affairs

Bachelor’s degree in Quality Assurance

Bachelor’s degree in Engineering

Bachelor’s degree in a related science field

Tools

Quality Management Systems (QMS)

SAP

Jobbeschreibung

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Senior Regulatory Specialist (m/f/d) - IVD, Stuttgart

Client: Agilent

Location: Stuttgart, Germany

Job Category: Other

EU work permit required: Yes

Job Reference: 8ce7c4395aaa

Expiry Date: 26.06.2025

Job Description:

Overview

Agilent is committed to advancing the quality of life through innovative solutions in life science, diagnostics, and applied markets. We support laboratories worldwide with instruments, services, consumables, applications, and expertise, enabling our customers to achieve insights that improve the world. For more information, visit our website.

Position Summary

We are seeking a highly motivated Senior Regulatory Specialist (m/f/d) to join our Global Regulatory Affairs team. You will play a key role in supporting new product launches and developing regulatory strategies to bring products to the global market. Your responsibilities include coordinating international submissions, managing product change notifications, licensing, and registration of IVD products.

The role ensures products are received, licensed, and delivered in compliance with global regulatory and quality standards. As part of the team, you will support IVD registrations internationally, including:

• Preparing documentation for regulatory submissions and listings, ensuring compliance with local and regional requirements.
• Maintaining export licenses within SAP and addressing global trade issues.
• Developing programs to ensure product safety, legality, and compliance with regulations.
• Monitoring regulatory changes and advising stakeholders of potential impacts.
• Leading regulatory projects and coordinating with Legal, Marketing, Project Management, and distributors.
• Supporting change controls and preparing documentation for permits, licenses, and registrations.
• Consulting with regulatory agencies for guidance.
• Communicating with channel partners regarding registrations and changes.

Location

This position is preferably based in our Waldbronn office in Germany (hybrid model) but can be located anywhere in Europe where Agilent operates.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, Engineering, or a related science field.
• Several years of relevant experience in a regulated environment.
• Knowledge of international registration processes.
• Strong teamwork and leadership skills across functions and geographies.
• Experience with Quality Management Systems (QMS) in the medical devices industry.
• Proficient in English, both written and spoken.

Preferred Qualifications

• Excellent communication, project management, and presentation skills.
• Knowledge of design controls and standards such as ISO 13485 and 14791.
• Experience with regulated products, ISO standards, and IVD regulations.

What We Offer

• Comprehensive global benefits, including bonuses, private healthcare, pensions, stock plans, and insurance.
• Opportunities for professional growth in a global company.
• Diversity and inclusion initiatives.
• A dynamic, collaborative, and agile work environment.
• Work-life balance and a permanent contract.

Application

We look forward to receiving your application in English.

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