Cook Medical Europe Ltd
Address: O’Halloran Road, National Technology Park, Limerick,Social Media
Facebook : https://www.facebook.com/cookmedical/About Us
We are family owned, but we are not small. More than 12,000 people around the world call themselves Cook employees, and we work with many distributors who we consider an extension of Cook. Our sales representatives can be found in most countries through Europe.
Sectors
- Medical Devices
Categories
- Medical Devices
Certifications
- ISO 13485 Quality Management-Medical Devices
Job Vacancies
Position:
Director, Regulatory Affairs - CIRL
Description:
The Director of Regulatory Affairs is responsible for Cook Ireland's regulatory strategy and systems, and for ensuring that the company's products meet regulatory requirements in markets where they are for sale; including appropriate reporting of adverse incidents where applicable. The Director of Regulatory Affairs is also responsible for working with sister manufacturers, to assist with communications with relevant authorities and to provide clarification and advice on regulatory requirements. The successful candidate will be a member of the CIRL Senior Management Team and the Global Regulatory Affairs Leadership Group.
Category:
Regulatory Affairs
Posted:
10-Dec-18
Closing:
31-Jan-19
Web Link:
https://emea-cookmedical.icims.com/jobs/5614/director,-regulatory-affairs---cirl/job
Position:
Regulatory Affairs Associate
Description:
Obtains and maintains an understanding global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 and become proficient / knowledgeable in global medical device regulations.
Develop a thorough understanding of the medical devices they are assigned.
Assist in the implementation of global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), on all classes of devices.
Plans and prepares regulatory submissions for specific target markets for new products, product changes and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
Maintains registration information (license numbers, expiration dates, regulatory logs for annual reports, filing / printing of regulatory submissions, correspondence etc).
Develop a thorough understanding of the medical devices they are assigned.
Assist in the implementation of global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), on all classes of devices.
Plans and prepares regulatory submissions for specific target markets for new products, product changes and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
Maintains registration information (license numbers, expiration dates, regulatory logs for annual reports, filing / printing of regulatory submissions, correspondence etc).
Category:
Regulatory Affairs
Posted:
22-Mar-18
Closing:
31-May-18
Web Link:
https://www.linkedin.com/jobs/view/579168789/
Position:
CUSTOMER QUALITY ASSURANCE TECHNICIAN
Description:
Work as part of the Customer Quality Assurance group to provide an efficient service to our customers internally and externally in dealing with product complaints.
Category:
Quality Assurance
Posted:
18-May-17
Closing:
20-Jul-17
Web Link:
https://emea-cookmedical.icims.com/jobs/2389/european-customer-quality-assurance-technician/job
Position:
Regulatory Affairs Specialist
Description:
The Regulatory Affairs Specialist helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The regulatory affairs specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.
Category:
Regulatory Affairs
Posted:
18-May-17
Closing:
22-Jun-17
Web Link:
https://emea-cookmedical.icims.com/jobs/2273/regulatory-affairs-specialist/job
Position:
Manufacturing Operations Manager
Description:
The primary purpose of this position is to provide leadership and direction to the manufacturing operations function within Cook Medical, this includes managing Production Managers and Operations Analyst in accordance with policies and procedures to implement and carry out company goals providing direction/guidance to ensure that expectations and goals are clear and understood.
Category:
Production & Operations
Posted:
18-May-17
Closing:
22-Jun-17
Web Link:
https://emea-cookmedical.icims.com/jobs/2151/manufacturing-operations-manager/job
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