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

TN United Kingdom; Church Stretton; Hybrid; GBP 45,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Senior Regulatory Specialist, where you will play a crucial role in supporting new product introductions and developing regulatory strategies for IVD products. This position offers the chance to work in a dynamic environment, ensuring compliance with global standards while collaborating with diverse teams. You will be involved in preparing regulatory submissions, leading projects, and monitoring changes in regulations. With opportunities for growth and a supportive culture, this role is perfect for those passionate about making a difference in the life sciences field.

Benefits

Comprehensive global benefits

Private healthcare

Pension plans

Stock plans

Insurance

Opportunities for growth

Inclusive culture

Work-Life Balance initiatives

Permanent contract

Qualifications

• Several years of relevant experience in regulated environments.
• Experience with international registrations and compliance.

Responsibilities

• Prepare document packages for regulatory submissions and listings.
• Monitor regulatory changes and communicate potential risks.
• Lead regulatory projects and coordinate with various teams.

Skills

Regulatory Affairs

Quality Assurance

Project Management

Communication Skills

Teamwork

English Proficiency

Education

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

SAP

Quality Management Systems (QMS)

Job description

Social network you want to login/join with:

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

col-narrow-left

Client:

Agilent

Location:

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

46f6dcc71543

Job Views:

4

Posted:

02.05.2025

Expiry Date:

16.06.2025

col-wide

Job Description:

Description

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 !

We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team where you will play a key role in supporting new product introduction projects and developing regulatory strategies to help bring products to the global market. Your responsibilities will include coordinating and tracking international submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent’s IVD portfolio.

The role ensures products are received, licensed, and delivered in accordance with global regulatory and quality standards. As a member of the Global Regulatory Team, you will:

• Prepare document packages for regulatory submissions and listings, ensuring compliance with local and regional registration requirements and company policies.
• Compile materials required for submissions, license renewal, and annual registrations. Maintain export licenses within SAP for IVD licenses and address global trade holds.
• Develop and implement programs and processes to ensure product safety, legality, and compliance with regulations.
• Identify and escalate regulatory and compliance issues to senior management as needed.
• Monitor regulatory changes and participate in discussions related to regulation updates, communicating potential risks and opportunities.
• Lead regulatory projects, coordinating with Legal, Marketing, Project Management, and distributors.
• Support impact assessments for change controls on registered products.
• Coordinate the preparation of documentation for permits, licenses, and registrations.
• Consult with regulatory agencies for guidance on regulations.
• Communicate with Channel Partners regarding registrations and change assessments.

This position is preferably based in our Waldbronn office in Germany (hybrid), but can also be located anywhere in Europe where Agilent has an entity.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, Engineering, or a related science field
• Several years of relevant experience in regulated environments
• Experience with international registrations
• Strong teamwork skills and ability to lead and collaborate across functions and geographies
• Experience with Quality Management Systems (QMS) for medical devices
• Proficient in English, both written and spoken

Preferred Qualifications

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

We offer:

• Comprehensive global benefits, including bonuses, private healthcare, pension, stock plans, and insurance (varies by country)
• Opportunities for growth and career development in an international setting
• Inclusive culture and diverse perspectives
• Autonomous work environment with supportive colleagues
• Exciting projects within a dynamic, agile team
• Work-Life Balance initiatives
• Permanent contract in a growing global company

We look forward to your application in English.

Agilent is recognized as one of the best employers globally: Awards | Agilent Technologies