Medical Product Manufacturing
Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future.
The Regulatory Affairs Specialist I is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in region specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor.
Job Functions/Duties (may include other duties as assigned)
- Serves as a liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor
- Communicates country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies
- Plans and prepares regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions
- Maintains registration information (license numbers, expiration dates, etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability
- May communicate directly with the regulatory authorities to ensure product approvals are achieved in a timely manner
- Performs translation activities as needed
- Collaborates with Regulatory Scientific Affairs on all high risk devices and new technologies
- Collaborates with the Clinical Functional Unit on projects requiring the collection of clinical data
- Provides support to currently marketed products as necessary including input on change requests, etc.
- Maintains and organizes appropriate regulatory records to demonstrate compliance with applicable regulations
- Performs additional duties as assigned
- Must work effectively with and for others to achieve company goals
- Must strictly adhere to safety requirements
- Maintain regular and punctual attendance
- Must maintain company quality standards
Minimumn Work Experience/Educational Requirements
- Proficient in reading, writing and speaking the English language
- 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.
- Works under general office environmental conditions.
- Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
- Requires occasional early morning or late evening teleconferences
- International and domestic travel as required
- Base Salary
- Teamwork bonus
- 401(k) retirement savings plan with company match
- Profit sharing
- Medical, dental, and vision
- Life insurance
- Paid time off
- Flexible spending account
- Educational assistance/reimbursement
Cook is an Equal Opportunity Employer
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...