Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage and interact directly with regulatory authorities to ensure timely product approvals when necessary.

• Convey country or region-specific regulatory requirements to the Regulatory Specialist and Regulatory Science team leaders, aiding in the development of regulatory strategies.

• Secure and uphold product approvals, acting as a communication bridge on regulatory matters between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor.

• Strategize and prepare regulatory submissions for new products, modifications, and re-registrations as mandated for specific countries or regions.

• Keep registration details updated (such as license numbers and expiration dates) and proactively obtain re-registration approvals before license expirations to ensure uninterrupted product availability.

• Execute translation tasks as needed.

• Offer support for currently marketed products, including providing feedback on change requests.

• Collaborate with Regulatory Scientific Affairs on all high-risk devices and innovative technologies.

• Partner with the Clinical Functional Unit on projects that necessitate the collection of clinical data.

• Organize and maintain relevant regulatory records to demonstrate compliance with applicable regulations.

⛳️ Requirements

• Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or a related field (such as law).

• Proficient in reading, writing, and speaking regional language(s).

• A minimum of 3 years of relevant experience.

🏝️ Benefits

• Flexible work arrangements.

• Professional development opportunities.