Regulatory Affairs Specialist - Remote
Cook Group
Bloomington, IN
Expired: January 08, 2022
Applications are no longer accepted.
- Full-Time
Overview
The Regulatory Affairs Specialist at Cook Inc. is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the Cook manufacturer and the Cook Local Office / Cook Distributor.
Responsibilities
• Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor
• Communicate region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies
• Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific 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
• 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
Qualifications
• Bachelor's degree in a related field preferred; Associates degree in Regulatory Affairs; or experience of such kind and amount as to provide a comparable background
• Proficient in reading, writing and speaking the English language
Physical Requirements:
• Requires occasional early morning or late evening teleconferences
• International and domestic travel as required
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
The Regulatory Affairs Specialist at Cook Inc. is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the Cook manufacturer and the Cook Local Office / Cook Distributor.
Responsibilities
• Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor
• Communicate region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies
• Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific 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
• 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
Qualifications
• Bachelor's degree in a related field preferred; Associates degree in Regulatory Affairs; or experience of such kind and amount as to provide a comparable background
• Proficient in reading, writing and speaking the English language
Physical Requirements:
• Requires occasional early morning or late evening teleconferences
• International and domestic travel as required
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
Address
Cook Group
750 Daniels Way
Bloomington, IN
47404
USA
Industry
Government
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