Join to apply for the Regulatory Affairs Associate III role at Katalyst CRO Join to apply for the Regulatory Affairs Associate III role at Katalyst CRO Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations. Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines. With oversight, understand and respond to regulatory agency correspondence. Evaluates manufacturing and labelling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review. Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team. Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission. Identify registration documentation deficiencies and work with colleagues to accomplish resolution. Understand global regulations and assure regulatory compliance, minimizing development costs and cycles. Prepare and maintain regulatory strategy with supervision. Exercise good judgment within policy and regulations. Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters. Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management. Presents scientific data effectively orally and in writing in a logical and persuasive manner. Provides daily regulatory support to new product development teams and commercial support with guidance. Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution. Acts with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management. Responsibilities Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations. Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines. With oversight, understand and respond to regulatory agency correspondence. Evaluates manufacturing and labelling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review. Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team. Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission. Identify registration documentation deficiencies and work with colleagues to accomplish resolution. Understand global regulations and assure regulatory compliance, minimizing development costs and cycles. Prepare and maintain regulatory strategy with supervision. Exercise good judgment within policy and regulations. Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters. Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management. Presents scientific data effectively orally and in writing in a logical and persuasive manner. Provides daily regulatory support to new product development teams and commercial support with guidance. Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution. Acts with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management. Requirements: Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject. RAC Certification is preferred. A minimum of 2 years of experience in the Medical Products Industry in Regulatory Affairs. Able to assess scientific arguments and apply analytical and logical reasonings. Ability to effectively prioritize workload and multitask with minimal supervision. Good interpersonal skills. Good oral and written communications skills. Demonstrated project management skills. Demonstrated critical thinking, contingency planning and negotiating skills. Understanding of regulatory and business needs with ability to engage cross functional team members. Seniority level Seniority level Entry level Employment type Employment type Contract Job function Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Associate jobs in San Clemente, CA . 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