Agilent Technologies, Inc. RA/QA Program Manager in México, Mexico
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.
The Regulatory Affairs Project Lead in Mexico will support South America, Central America or Spanish language regions as well.
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. 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 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.
The key focus is to draft/assemble submission package, update regulatory submissions and support of post market activities.
Familiar with Mexico quality requirements for products and facility.
Support local business establishment and obtain required license
Lead and support product quality needs including complain handling, recall, etc.
Leads the design/ delivery of new programs/ solutions; is the key technical contributor
Solves complex, high impact program/ project design problems
Bachelors or Masters Degree or University Degree or equivalent. Typically 7+ years relevant regulatory experience. Post-graduate and/or certification/ license may be required. Requires specialized depth and/or breadth of expertise in job.
Agilent is an equal opportunity employer.
Date Posted: 18/Oct/16
Job Title: RA/QA Program Manager
Business: Global Infrastructure
Job Category: Quality/Regulatory
Job Sub-Category: Regulatory
Country or Area: Mexico
State/Province: Distrito Federal
Shift: Day Job
Job Type: Experienced
Travel Required: No
Duration (Temp Positions Only): Not applicable