Regulatory Affairs Specialist 2

About the role

This is a remote position focused on a specific country and/or region where the Specialist has proficient language skills (reading, writing, speaking). The role requires business-level proficiency in the region's language to communicate with regulatory authorities, Cook International Local Offices, or distributors. The Regulatory Affairs Specialist II assists in developing regulatory strategies, obtaining and maintaining approvals, and serving as a liaison between Cook manufacturers and international offices or distributors.

Responsibilities

• Communicate and interface directly with regulatory authorities to ensure timely product approvals.
• Communicate country/region-specific regulatory requirements to Regulatory Specialist/Regulatory Science team leaders and assist with regulatory strategies.
• Obtain and maintain product approvals and serve as a liaison on regulatory issues between Cook manufacturers and Cook International Local Offices or distributors.
• Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for specific countries/regions.
• Maintain registration information (license numbers, expiration dates, etc.) and secure re-registration approvals in advance to prevent disruptions in product availability.
• Perform translation activities.
• Provide support for currently marketed products, including input on change requests.
• Collaborate with Regulatory Scientific Affairs on high-risk devices and new technologies.
• Collaborate with the Clinical Functional Unit on projects requiring clinical data collection.
• Maintain and organize 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 regulatory requirements.

Requirements

• Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or other related field (such as law); or equivalent experience.
• Proficient in reading, writing, and speaking the region-specific language(s).
• 3 years of prior relevant experience.
• Legally authorized to be employed in the United States (Cook does not intend to provide sponsorship for employment visa status).

Physical Requirements

Works under general office environment conditions. Utilizes close visual acuity for working with computers and equipment. Frequently required to sit, stand, walk, and communicate. May require occasional early morning or late evening teleconferences.