Senior Regulatory Affairs Specialist
Medtronic
Associate II, Regulatory Affairs
ICU Medical
full-time
Posted on:
Location Type: Hybrid
Location: Southington • Connecticut • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- 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.
- 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.
Requirements
- Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- RAC Certification preferred
- A minimum of two years of experience in 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.
- Must be at least 18 years of age.
Benefits
- This is largely a sedentary role.
- This job routinely uses standard office equipment.
- Typically requires travel less than 5% of the time.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceglobal regulatory strategiesregistration dossierschange managementregistration packagesregulatory agency correspondencemanufacturing changes evaluationlabeling changes evaluationanalytical reasoningproject management
Soft skills
interpersonal skillsoral communicationwritten communicationprioritizationmultitaskingcritical thinkingcontingency planningnegotiating skillsengagement with cross-functional teams
Certifications
Bachelor's DegreeRAC Certification
