Regulatory Affairs Specialist

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🕒 April 29

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Cook Group

WebsiteLinkedInAll Job Openings

11 - 50 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical devices

Cook Group is a family of ethical and entrepreneurial companies with roots in medical devices and a commitment to empowering people and communities. Headquartered in Indiana and with a global footprint, Cook Group operates in various sectors, including life sciences, property management, and resort and service businesses. The company's mission is driven by values of integrity, quality, respect, and transparency, focusing on innovative solutions that meet the needs of employees, customers, and communities.

📋 Description

• 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. • Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.

🎯 Requirements

• Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or other related field (such as law); • Proficient in reading, writing and speaking region specific language(s). • 3 years of prior relevant experience

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities