Description Position Summary
Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables. With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.
Essential Duties & 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 labeling 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.
Knowledge & Skills
•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.
Minimum Qualifications, Education & Experience
•Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
•RAC Certification preferred
•Three plus years of experience in Medical Products Industry with a minimum of 2 years of experience 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.
•Must be at least 18 years of age
Work Environment
•This is largely a sedentary role.
•This job routinely uses standard office equipment.
•Typically requires travel less than 5% of the time
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
