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Company Contact Info
- Santa Ana, CA
- Ashi Khandelwal
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Regulatory Affairs Specialist
Integrated Resources, Inc • Santa Ana, CA
Posted 1 month ago
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Regulatory Affairs Specialist –
Location: Santa Ana CA//Milpitas, CA
Duration: 06 months+
This position is an entry to mid-level professional position in Regulatory Affairs to support implementation and compliance with the EU Medical Device Regulations. Primary responsibilities include support and assistance in preparation, submission, and maintenance of global regulatory documents/dossiers under direct supervision.
Adheres to environmental policy, procedures, and supports department environmental objectives.
1. Prepares, compiles and submits global regulatory dossiers, US and International for new and existing products.
2. Complete Regulatory Impact assessments for product, process and package changes and communicate results to the appropriate departments.
3. Coordinate and assist in the maintenance of licenses and authorizations for existing products (e.g., US PMA, International Registrations and Dossiers, updates to technical files), engineering and device changes requests.
4. Participates in cross-functional project teams
5. Coordinates and assists in the review and approval of new and/or revised product labeling to ensure regulatory compliance.
6. Provides Regulatory Affairs support during internal and external audits (as needed).
7. Update Regulatory Affairs procedures as needed to comply with EU MDR Requirements.
Minimum education required for competent performance:
BS degree (scientific discipline preferred) or equivalent
1-3 years of experience with a BS degree (scientific discipline preferred) or equivalent
Personal computer, printer, telephone, facsimile, copier, calculator, software as required
Typical office environment
Give no supervision to others.
How work is done and work progress are checked under close supervision and/or clearly defined procedures.