Regulatory Affairs Specialist

The Regulatory Affairs Specialist II develops regulatory strategies,obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook international office / Cook distributor. This work is completed with little to no direction from Management.

• Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner
• Communicate country/region-specific regulatory requirements to the project leaders and assist with the regulatory strategies
• Develop regulatory strategies, obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook international office/ 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

• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and
independent work situations and environments with minimal supervision.

• Minimum 2 years regulatory affairs experience with medical devices
• Bachelor’s degree in business, 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

Physical Requirements:

• Fully remote position ( do not need to reside in NC)
• Interacts with colleagues using remote meeting tools such as MS Teams
• Requires close visual acuity when working with computers, etc.
• Requires occasional early morning or late evening meetings
• Travel as required (rare)

**Qualified candidates must be legally authorized to be employed in the United States.  Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.