(Archived) Diagnostics Regulatory Affairs Manager

Zoetis is seeking a team player to fill the position of Regulatory Affairs Manager. The right candidate will bring advanced regulatory experience to our Global Diagnostics Regulatory Affairs team and will serve as a subject matter expert responsible for developing innovative pre-market regulatory affairs strategies for IVD hardware, software and consumables.

Job Duties Include but not limited to:

ᴑ Leader of 2-4 direct reports.

ᴑ Participate on product design teams by providing the regulatory strategy for new products or new claims for existing products.

ᴑ Assist in preparation of documentation needed for regulatory submissions.

ᴑ Serve as an alternate Liaison with USDA.

ᴑ Assure products compliance with Software, Firmware and Hardware Regulations.

ᴑ Provide support in review of label structure and content.

ᴑ Conduct risk assessments and review study reports

ᴑ Write and update technical files.

ᴑ Perform MDR evaluations and report adverse events.

Requirements:

• BS/BA, MS in science, regulatory affairs or health related field
• Strong in vitro diagnostics background
• Understanding of enzymatic, immunoassay or organic chemistry helpful
• System level experience in diagnostics or medical device development in an FDA regulated industry
• Experience with 510(k)/CLIA requirements preferred
• Systems orientation to product development
• Familiarity/experience with manufacturing processes
• Ability to establish goals and hold direct reports accountable to those goals
• Demonstrated commitment to on time delivery and highest quality standards
• Proficient in MS Office (especially Excel) and similar applications
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions
• Written Communication - Writes clearly and informatively; able to read and interpret written information.
• Problem Solving - Identifies and resolves problems in a timely manner; uses reason even when dealing with emotional topics
• Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.