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.
This position provides regulatory support to the companion diagnostics division. The position supports the advancement of drug/diagnostics between Agilent and leading pharmaceutical partners. The position ensures compliance to medical device and IVD regulations both domestically and globally and is a key technical contributor to broad business concepts and strategies leading to the design and delivery of new products. Ability to solve complex, high impact project design issues is required.
Duties of the Professional Regulatory Specialist include:
- Contributes to the development and implementation of programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
- Prepares 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 regulatory requirements.
- Proactively manages the changing regulatory environment for company products, prevents 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.
- Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
- Represents the company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
- May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
- Works on company regulatory assignments with broadly defined objectives
- Solves straight-forward issues, challenges and problems within area of specialization.
- Determines and develops approaches to assignments
- Leads regulatory projects requiring coordination with other functions, third parties
- Potential for growth into supervisry role
Associated topics: aseptic technique, cytometry, dietetic, dietician, healthcare, histotechnologist, immunology, medicine, microbiological, microbiology