If you are a Regulatory Affairs professional with a track record in Medical Devices, please read on!
Job Title: Regulatory Specialist- Oversee the process of obtaining FDA Approvals, CE Mark, and other foreign regulatory approvals.
- Handle regulatory submissions and registrations
- IDE, PMA, 510(k), Design Dossiers, Technical Files, and other regulatory filings.
- Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.
- Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
- Work interdepartmental with Engineering & R&D product development project teams
- Successful track record in Regulatory Affairs
- Current knowledge of FDA Guidelines
- History of Medical Device directives (93/42/EC)
- Strong understanding of ISO 13485
We are actively interviewing so APPLY TODAY!
Benefits
Vacation/PTO
Medical
Dental
Vision
401k
Bonus
Relocation
Telecommute
Applicants must be authorized to work in the U.S.
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