1 Regulatory Affairs Specialist - Medical Devices (Fully Remote) AK Job in Round Lake, IL
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Regulatory Affairs Specialist - Medical Devices (Fully Remote) AK
$73k-96k (estimate)
Full Time
2 Weeks Ago
Cube Hub Inc. is Hiring a Remote Regulatory Affairs Specialist - Medical Devices (Fully Remote) AK
DescriptionM-F 8 - 5
Fully remote
Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global Baxter’s products.
Essential Duties And Responsibilities
Fully remote
Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global Baxter’s products.
Essential Duties And Responsibilities
- Supports regulatory project plan execution
- Maintain awareness of regulatory requirements and ensure continued learning
- Maintain regulatory files in a format consistent with requirements
- Participate as an active team member of project teams as required
- Compile and prepare responses to questions from regulatory authorities according to plan
- Edit and proofread regulatory documentation
- Assist in preparation and review of labeling, SOP’s, and other departmental documents
- Compile under supervision regulatory documents for submission
- Track status and progress of regulatory documentation
- Understand Regulatory Affairs' position in small project teams
- Knowledge of regulations
- Scientific knowledge
- Administrative and project management skills
- Ability to contribute to multiple projects from a regulatory affairs perspective
- Ability to multitask and prioritize
- Interpersonal and communication skills
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Proofreading and editing skills
- Bachelor’s degree or country equivalent in a relevant scientific discipline
- Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification
- Regulatory experience (not mandatory) preferably within a healthcare environment
- Familiar with USA and OUS device regulations (specifically EU device regulations)
- Experience with RA strategy development
- Experience with working with Cross functional team members
- Experience with interaction with external Regulators (FDA, TUV)
- Experience with working with medical devices
Job Summary
JOB TYPE
Full Time
SALARY
$73k-96k (estimate)
POST DATE
06/12/2024
EXPIRATION DATE
12/07/2024
WEBSITE
cube-hub.com
HEADQUARTERS
Aurora, IL
SIZE
<25
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