Overview

This is a REMOTE position.   The Regulatory Affairs Specialist 2 responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to speak, read and write in business level region specific language for purposes of communicating with regulatory authorities and international local Cook offices or distributors. The Regulatory Affairs Specialist II assists in development of regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor.

Responsibilities

- 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.

Qualifications

- 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).

 

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.- Requires occasional early morning or late evening teleconferences.