Regulatory Affairs Specialist
Artivion, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Kennesaw • United States
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About the role
- Support manufacturing site needs to meet local objectives and maintain regulatory compliance.
- Provides support for product regulatory compliance maintenance activities for approved products.
- Responsible to maintain compliance for marketed products, including review of labeling, promotional material, product change assessments and documentation for changes.
- Support regulatory commercialization activities, including listing and authorization within the enterprise resource system and/or other related databases.
- Support regulatory compliance activities, including facility site registrations, audits, etc., as needed.
- Work with cross-functional teams and subject matter experts to maintain regulatory compliance.
- Team with international regulatory colleagues to provide regulatory support for changes to existing products.
- Align with RA leadership on the reviews needed for significant product submissions with project stakeholders.
- Author accurate and complete submission content with support from management.
- Provide feedback and on-going support to product teams for regulatory questions.
- Generates and executes regulatory or compliance activities under management direction.
- Maintain awareness/have a beginner to intermediate understanding of worldwide regulatory requirements; maintain awareness of agency relationship and ensure RA leadership is prepared with sufficient information to support relationships with external agency personnel.
- Provide basic project management techniques for task management and deliver to defined plans.
Requirements
- Bachelor's degree and a minimum of 2 years of regulatory experience or an advanced degree with a minimum of 1 years of regulatory experience.
- Experience with medium to high risk, FDA Class II or III devices or experience with EU Class IIb or III devices.
- Experience working with cross-functional teams.
- Ability to comprehend principles of engineering, physiology, and medical device use.
- Ability to effectively manage and prioritize numerous projects and responsibilities.
- Strong analytical, technical writing, verbal/written communication, organizational, and time management skills.
- Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.
Benefits
- Health insurance
- Retirement plans
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory compliancetechnical writingproject managementlabeling reviewpromotional material reviewproduct change assessmentfacility site registrationauditsFDA Class II devicesEU Class IIb devices
Soft Skills
analytical skillsverbal communicationwritten communicationorganizational skillstime managementflexibilityadaptabilityinitiativeleadershipteam collaboration
Certifications
Bachelor's degreeadvanced degree