Regulatory Affairs Expert

Additional location:

• Denmark - Hovedstaden - Copenhagen
• Denmark - Fyn - Odense

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.
• Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
• Prepare document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
• Compiles materials required in submissions, license renewal, and annual registrations and maintains updated information about national/regional/global requirements.
• Proactively manages the changing regulatory requirement for company products, prevent barriers to trade, eliminates duplication of effort, and identifies and mitigates areas of risk.
• Reviews product labeling and marketing materials for accuracy and compliance with regulations.
• Represents the company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
• Driving product care initiatives and design changes to existing products.
• Lead regulatory projects requiring collaboration and coordination cross-functionally with R&D, Quality, and other business units.
• Solves a broad range of problems of varying scope and complexity
• 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.
• At least +8 years relevant experience for entry to this level.
• 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
Location: Denmark-Glostrup

Additional location:

• Denmark - Hovedstaden - Copenhagen
• Denmark - Fyn - Odense