Regulatory Affairs Associate I (REMOTE)
25212 W. Illinois Route 120 Round Lk Bch, IL 60073 US
Job Description
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 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, SOPs, 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
Qualifications
- 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
Education and/or Experience
- Bachelors 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
Top 3-5 technical skill requirements-
- 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
- Knowledge of Excel, Word, Power Point
Remote** CO and NYC candidate may not be considered
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.