GPD Career Course: Skills for Regulatory Affairs

DutiesPreparation of course content; Teaching a two-hour class, Wednesdays 4-6 pm; Development, administration, and marking of assignments; calculation and submission of grades; holding regular office hours Minimum Qualifications The successful candidate is required to have a graduate degree in biomedical science or related discipline. The successful candidate is required to have expertise in in vitro diagnostics across the full product lifecycle, from development through post-market activities and expertise in regulatory strategy development, including balancing time to market with the achievement of optimal labeling claims. The successful candidate must have global regulatory experience, including preparation and submission of pre-market registrations in key jurisdictions (Canada, United States, European Union). The successful candidate must have regulatory affairs experience, ideally including leadership or managerial responsibilities. The successful candidate should have contribute...