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

TN Switzerland; Basel; Vor Ort; CHF 80’000 - 110’000; Vollzeit

Zusammenfassung

An established industry player is looking for a Senior Regulatory Specialist to join their Global Regulatory Affairs team. In this pivotal role, you will support new product introductions, develop regulatory strategies, and ensure compliance with international regulations for IVD products. This dynamic position offers the opportunity to collaborate with various departments and engage with regulatory agencies, making a significant impact on product safety and legality. If you are passionate about regulatory affairs and thrive in a collaborative environment, this role could be your next career step.

Leistungen

Comprehensive benefits

Career growth opportunities

Dynamic, inclusive work environment

Qualifikationen

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

Aufgaben

• Prepare documentation for regulatory submissions ensuring compliance.
• Lead regulatory projects, coordinating with various teams.

Kenntnisse

Regulatory Affairs

Project Management

Communication Skills

Leadership Skills

QMS Knowledge

Ausbildung

Bachelor’s degree in Regulatory Affairs

Engineering or related science field

Tools

SAP

Jobbeschreibung

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

Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek — so they can do what they do best: improve the world around us. Want more information on Agilent? Check out our website.

Job Overview

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 introduction projects, developing regulatory strategies, and coordinating international submissions, product change notifications, licensing, and registration of IVD products.

Key Responsibilities

1. Prepare documentation for regulatory submissions and listings, ensuring compliance with local and regional requirements.
2. Maintain export licenses within SAP and address global trade holds.
3. Develop and implement programs to ensure product safety, legality, and compliance with regulations.
4. Monitor regulatory changes and communicate impacts to internal teams.
5. Lead regulatory projects, coordinating with Legal, Marketing, Project Management, and distributors.
6. Support change control assessments and prepare documentation for permits and licenses.
7. Consult with regulatory agencies for guidance and interpretation.
8. Communicate with channel partners regarding registrations and assessments.

Qualifications

• Bachelor’s degree in Regulatory Affairs, QA, engineering, or related science field.
• Several years of experience in a regulated environment.
• Knowledge of international registration processes.
• Strong teamwork and leadership skills across functions and geographies.
• Experience with QMS in the medical device industry.
• Proficient in English communication skills.

Preferred Qualifications

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

Additional Information

This position is preferably based in Waldbronn, Germany (hybrid), but can be located anywhere in Europe where Agilent has an entity. The role involves approximately 10% travel. We offer comprehensive benefits, career growth opportunities, and a dynamic, inclusive work environment.