Regulatory Affairs Expert

Regulatory Affairs Expert

Agilent Technologies

Glostrup, Copenhagen or Odense, Denmark

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.