Regulatory Affairs Specialist job in Andover, MA
Vacancy has expired
Andover, MA CorTech LLC
| Job Ref: | 358202 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 38.46/Per Hour |
| Remote: | No |
Location |
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| City: | Andover, MA |
| Post Code: | 1810 |
| Map: |
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Description |
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Seeking to hire a Regulatory Affairs Specialist for my client in Andover, MA 1810 Benefits and weekly pay available 38.46 per hour Hybrid Role Overview include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc. Through coordination collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance approval. Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registrations with FDA and EU Notified Body.Maintains databases as required.Supports regulatory compliance projects as assigned. Responsibilities Approximate the percentage of work associated with each responsibility. Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines. Initiates, reviews and approves technical documentation, product labeling, and product instructions for use changes for compliance with applicable regulations. Trains to and executes document management within local Product Lifecycle Management system and other electronic documentation systems as applicable. Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements. Other activities as assigned. | |
ref: (358202)
less than 2 minutes ago
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