Regulatory Affairs Specialist - Sr job in Cordova, TN
Cordova, TN CorTech LLC
| Job Ref: | 373692 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 39.28/Per Hour |
| Remote: | No |
Location |
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| City: | Cordova, TN |
| Post Code: | 38018 |
| Map: |
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Description |
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JobsRUs.com is seeking to hire a Regulatory Affairs Specialist-Sr for our client in Cordova, TN! Benefits Available! Weekly Pay! $39.28/Hour JOB DESCRIPTION: Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company?s product launch timelines in all identified markets. Manage or lead regulatory-driven project, as directed by management. Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology Plan, lead and support for internal and Regulatory agency audits Lead and direct engagement with regulatory authorities as required Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements. Provides technical guidance and regulatory training or mentoring to other Regulatory Affairs employees and cross-functional teams. Review product labeling to ensure compliance with regulatory requirements Other activities as assigned. | |
ref: (373692)
9 days ago
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