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

Social network you want to login/join with:

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

Client: Agilent

Location: Waldbronn, Germany (hybrid model) or anywhere in Europe where Agilent has an entity

Job Category: Other

EU work permit required: Yes

Job Reference: 15bace9d5050

Job Views: 1

Posted: 11.05.2025

Expiry Date: 25.06.2025

Job Description:

Overview

Agilent provides life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. We are seeking a highly motivated Senior Regulatory Specialist (m/f/d) to join our Global Regulatory Affairs team. In this role, you will support new product introductions, develop regulatory strategies, coordinate international submissions, and ensure compliance of IVD products with global regulations.

Responsibilities include:

• Preparing documentation for regulatory submissions and listings to ensure compliance with local and regional requirements.
• Maintaining export licenses within SAP for IVD licenses and managing global trade holds.
• Developing and implementing programs to ensure product safety, legality, and compliance.
• Monitoring regulatory changes and assessing their impact on ongoing and future projects.
• Leading regulatory projects and coordinating with legal, marketing, project management, and distributor partners.
• Supporting regulatory impact assessments and preparing documentation for permits, licenses, and registrations.
• Consulting with regulatory agencies for guidance and interpretation of regulations.
• Communicating with channel partners regarding registrations and change assessments.

Qualifications:

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, engineering, or a related science field.
• Several years of experience in a regulated environment.
• Knowledge of international registrations and experience with global resources.
• Excellent teamwork, communication skills in English, and ability to lead and collaborate across functions.

Preferred Qualifications:

• Strong project management and presentation skills.
• Knowledge of design controls and standards such as ISO 13485 and 14791.
• Experience with regulated products and ISO Quality standards.

We Offer:

• Competitive global benefits, including bonuses, private healthcare, pension, stock plans, and insurance.
• Opportunities for professional growth within a global company.
• A diverse, inclusive, and collaborative work environment.
• Work-life balance and a permanent contract.

We look forward to receiving your application in English. For more information about Agilent, visit our website. This role requires travel up to 10% and is a day shift position. A valid work permit may be required if you are not a passport holder of the country of employment.