Global Regulatory Affairs Specialist Ii

Responsibilities New Product DevelopmentAct as Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teamsDevelop and maintain regulatory strategies for new and modified product / product familiesPrepare and execute regulatory filings such as technical files, Canadian submissions, and letters to file.Conduct international registrations in accordance with and in support of regulatory strategiesProvide input on and approve product labels and labelling including language requirements worldwideSupport set up and management of outside vendors such as License holders and In Country agents [including importers, distributors], as needed.Change ManagementProvide regulatory guidance on changes to existing productsMonitor global regulatory intelligence, provide impact evaluation to changing regulations.Performing regulatory impact assessments for engineering changesReview and approve promotional materialsPost MarketProvide regulatory input to support post market surveillance and vigilance activitiesSupport Health Hazard Assessments and Field Actions as needed Qualifications Education:Bachelor's degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering.
Graduate education is preferable.Experience:Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalentKnowledge and application of 21 CFR 820 and ISO 13485 is requiredKnowledge and application of the European IVD regulations is required, IVDR preferredFirst-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD productsSkills:High fluency in English, verbal and writtenCritical Thinking, Active Listening, and Technical Writing SkillsAble to work effectively in a global functionStrong ability to work with individuals/teams dispersed across many different locations and culturesStrong organization/prioritization skillsOutstanding Work Ethic.Effective communication and influencing skills.Team player demonstrating good organizational and communication skillsSelf-starting demonstrating initiative