Regulatory Affairs Manager, Intelligence
5301 Stevens Creek Blvd
Santa Clara, CA 95051
As a healthcare company committed to protecting the health and safety for our employees, contractors, customers and communities, employees in this role are required to be fully vaccinated against COVID-19, unless an accommodation has been granted for a medical reason or sincerely held religious belief.
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.
Agilent is seeking a highly skilled, motivated, and customer focused professional leader to join our team. This key position will develop and implement Agilent’s Regulatory Intelligence processes ensuring regulatory requirements are known, communicated, and implemented across Businesses.
This role is highly visible within the Global Regulatory Affairs team, working to help define a new structure for Agilent, identifying solutions and processes, and aligning with key partners on implementation of new requirements.
As a member of the Agilent Global Regulatory Team, this leader will provide guidance to the business teams on Regulatory requirements and assist where needed, during implementation following the One Agilent Quality processes.
- Establish sources of intel to thoroughly scan Agilent’s regulatory environment; determine which new or revised requirements should be assessed by Agilent for impact to our products and processes.
- Lead the assessment of these new or changed requirements in collaboration with cross-functional representatives, and ensure that this assessment, as well as plans to bring processes and products into compliance, are well documented
- Ensure that QMS documents are updated as needed to reflect new requirements
- Communicate new or changed requirements to Agilent stakeholders and partners
- Accountable for the Standards Committee and 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.
- Facilitate requests from the Businesses on related requirements.
- Bachelor’s degree (or equivalent) preferably in a science field
- Minimum of 8 years of experience in regulated industry, medical devices and/or IVD products highly desired
- A minimum of 5 years working directly in Regulatory Affairs
- A working knowledge of Regulatory Intelligence tools allowing for monitoring, identifying, interpreting, and applying Regulatory requirements
- In-depth knowledge of IVD Regulations
- Strong working knowledge of QMS requirements for IVDs
- Demonstrated ability to collaborate and work effectively in teams across different businesses, functions, and geographies
- Excellent communication and problem-solving skills; a self starter with the ability to motivate and develop others.
What will make you stand out
- Regulatory Affairs Certification
- Project Management skills