Regulatory Affairs Expert

Job Description

Agilent inspires 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. Information about Agilent is available at www.agilent.com.

Will you join us in the fight against cancer?

We are looking for a Regulatory Affairs Expert to join our dynamic and versatile team supporting the Pathology Division—a profitable and growing business within Agilent. This is your opportunity to play a key role in supporting and driving development projects and obtaining regulatory approvals for new IVD devices, including hardware, software, and immunochemistry technologies.

You will be part of a collaborative environment with a high degree of autonomy, allowing you to shape your own role while working with products across various regulatory classifications.

About Us and the Job:

You will be based in our Glostrup, Denmark office, working in an exciting and dynamic environment with team colleagues and stakeholders.

As a team, we continuously work on streamlining our workflows, and you will contribute to optimizing our regulatory processes.

Your Responsibilities Will Include:

• Leading regulatory activities for new product development and lifecycle management.
• Supporting incoming reagent inquiries and hosting stakeholder meetings.
• Planning, creating, and maintaining Design Control documentation in alignment with Agilent’s Quality Management System (QMS).
• Ensuring ongoing maintenance and compliance of risk management documentation.
• Driving product care initiatives and design changes to existing products.
• Supporting complaint handling and root cause investigations from a regulatory perspective.
• Collaborating cross-functionally with R&D, Quality, and other business units.
• Mentoring junior colleagues in the Global RA/QA function.

Qualifications

We are looking for a motivated individual with the following background:

• Proven expertise in IVDR or Medical Device Regulatory Affairs.
• Demonstrated ability to implement innovative regulatory programs and development concepts.
• Experience with Design Control and regulatory documentation.
• Strong analytical and critical thinking skills.
• Ability to work independently and drive results.
• Excellent interpersonal and communication skills.
• Master’s/PhD in Biology, Biochemistry, Biotechnology or similar.
• Knowledge of IHC, ISH, Flow cytometry or special stains is a plus.
• Full fluency in English. Danish is not required.

What We Offer:

• Outstanding company culture.
• A position in an international and dynamic workplace with exciting challenges and opportunities.
• A diverse work environment with many challenging tasks.
• Great colleagues and a strong team spirit.
• Company pension scheme, individual bonus plan, private health care, medical & life insurance.

We will make sure you get the training and development opportunities you need to become the best in your field.

Additional Details

This job has a full time weekly schedule.

Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required:

10% of the Time

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory