Regulatory Affairs Associate

Position Title : Regulatory Affairs Associate
Job Location:  Remote
Job Duration: 10 Months
Shift 8 to 5

Must have Skills/Attributes
FDA, Labeling, Regulatory Affairs, SOP
 

Position Description
Required Education
-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 preferred, preferably within a healthcare environment

Required Skills
-Familiar with USA and OUS device regulations (specifically EU device regulations)
-Experience with RA strategy development
-Experience working with cross-functional team members
-Experience with interaction with external Regulators (FDA, TUV)
-Experience with working with medical devices
-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

Job Description
-Responsible for the global coordination and preparation of documents/packages for regulatory submissions
-Review and evaluate technical and scientific data and reports required for submission in support of global Baxter's products
-Remote position with a flexible schedule
-Supports regulatory project plan execution
-Maintains awareness of regulatory requirements and ensures continued learning
-Maintains regulatory files in a format consistent with requirements
-Participates as an active team member of project teams as required
-Compiles and prepares responses to questions from regulatory authorities according to plan
-Edits and proofreads regulatory documentation
-Assists in preparation and review of labeling, SOPs, and other departmental documents
-Compiles under supervision regulatory documents for submission
-Tracks status and progress of regulatory documentation
-Understands Regulatory Affairs' position in small project teams