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.
- 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.