Intellectt Inc
Regulatory Affairs Specialist
Intellectt Inc, Santa Clara, California, us, 95053
Role:
Regulatory Affairs Project LeaderLocation:
Santa Clara, CA - 95054-1208Duration:
12 MonthsShift Timings:
8 am to 5 pmDuties
Assist in defining and implementing regulatory strategy and prioritiesCommunicate issues to management through project tracking and briefingsEngage effectively with internal and external stakeholdersDemonstrate strong verbal and written communication skills, including negotiation and conflict managementWork constructively with internal customers (scientists, marketing, quality assurance, product development) to solve problems and address regulatory needsManage and track broad, strategic projectsWrite clear and concise briefings and issue analysesTrack and ensure timely completion of regulatory strategies, scientific substantiation for product claims, and label/promotional material activitiesCommunicate regulatory requirements to project teams and internal customers effectivelyEducation
Bachelor’s degree requiredMaster’s degree preferredExperience
Minimum of 3 years of experience in regulatory affairsSkills
Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA)Familiarity with EU regulations and MDR Technical DocumentationExperience with PMA, IDE, and 510(k) submissionsAbility to prepare and submit products for international registration
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Regulatory Affairs Project LeaderLocation:
Santa Clara, CA - 95054-1208Duration:
12 MonthsShift Timings:
8 am to 5 pmDuties
Assist in defining and implementing regulatory strategy and prioritiesCommunicate issues to management through project tracking and briefingsEngage effectively with internal and external stakeholdersDemonstrate strong verbal and written communication skills, including negotiation and conflict managementWork constructively with internal customers (scientists, marketing, quality assurance, product development) to solve problems and address regulatory needsManage and track broad, strategic projectsWrite clear and concise briefings and issue analysesTrack and ensure timely completion of regulatory strategies, scientific substantiation for product claims, and label/promotional material activitiesCommunicate regulatory requirements to project teams and internal customers effectivelyEducation
Bachelor’s degree requiredMaster’s degree preferredExperience
Minimum of 3 years of experience in regulatory affairsSkills
Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA)Familiarity with EU regulations and MDR Technical DocumentationExperience with PMA, IDE, and 510(k) submissionsAbility to prepare and submit products for international registration
#J-18808-Ljbffr