Regulatory Affairs Specialist
Cook Group
full-time
Posted on:
Location Type: Remote
Location: United States
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About the role
- Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner, if needed.
- Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies.
- Obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor.
- Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions.
- Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
- Perform translation activities.
- Provide support to currently marketed products as necessary including input on change requests, etc.
- Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies.
- Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data.
- Provide support to currently marketed products as necessary including input on change requests, etc.
- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
Requirements
- Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or other related field (such as law); or experience of such kind and amount as to provide a comparable background.
- Proficient in reading, writing and speaking region specific language(s).
Benefits
- Health insurance
- 401(k)
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsproduct approvalregulatory strategiestranslation activitiesclinical data collectionregulatory records managementcompliance demonstrationquality management systemFDA 21 CFR 820ISO 13485
Soft Skills
communicationcollaborationorganizational skillsinterpersonal skills