Then Cook Medical may be the place for you. Because a lot of what makes this company special is the people. It’s that simple.
It’s the people we work for: We serve the patients who want to get better and the doctors who want simpler, more effective options. To do just that, we’re a family-owned company that develops, builds, and distributes devices for minimally invasive medicine
It’s the people we work with: We think that great ideas happen when a group of people with different backgrounds, experiences, and viewpoints work together to figure something out. We’re always looking for new ideas—no matter where they come from.
It’s the people we live with: It’s important to us that we are involved in all our communities and we want to give back. Our headquarters is in Indiana but we have six U.S. manufacturing facilities that supply products to patients worldwide. And we have offices and manufacturing in many different countries.
OverviewThe Regulatory Affairs Specialist is responsible for planning and executing all activities necessary for product registration and maintenance of product license, including change management and maintain good communication with all Cook manufacturing facilities and entities to obtain support wherever required.
Responsibilities- Write and review new product and change submission dossiers for Cook Medical's products in Thailand in accordance with authority and company requirements.
- Preparation and submission of additional licenses with Thai FDA such as License per Import and Special Access License.
- Negotiate with local authorities on behalf of Company objectives. Act as the key person to communicate and negotiate with local regulatory authorities.
- Understand and maintain database and systems used for regulatory controls and submission work.
- Create and maintain training materials to improve awareness on Thailand regulatory landscape for colleagues across Cook Medical manufacturing sites and entities where necessary.
- Keep up with Thailand regulatory requirements and inform relevant internal parties on a timely manner. Update Cook Medical manufacturers and key stake holders of any changes in local regulatory requirement and assist to ensure affected parties fully understand the changes and impact. Provide strategy or solutions to meet local regulatory requirements.
- Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirement.
- Degree in Science, Engineering or other related discipline.
- At least 3 years working experience in regulatory field for medical device or pharmaceutical industry would be an advantage, preferably in multinational companies.
- Experience in regulatory submission work and negotiation with regulatory authorities.
- Excellent communication and interpersonal skills, able to work with people from different levels internally and externally.
- Excellent time management and organizational skills. Able to perform duties with limited supervision and meet deadline.
- Fluent in English and Thai (both spoken and written).
- Skilled in document management, able to multi-task and prioritize tasks.
- High level of computer skills including Microsoft Office.
- Positive attitude, open to changes, good team player, and attentive to details.
Skills Required
- Degree in Science, Engineering, or a related discipline
- At least 3 years of regulatory experience in the medical device or pharmaceutical industry
- Experience with regulatory submissions and negotiations with regulatory authorities
- Excellent written and verbal communication and interpersonal skills
- Ability to work with people at different internal and external levels
- Excellent time management and organizational skills
- Ability to work with limited supervision and meet deadlines
- Fluency in English and Thai, spoken and written
- Document management, multitasking, and prioritization skills
- High level of computer skills, including Microsoft Office
- Positive attitude, adaptability, teamwork, and attention to detail
What We Do
At Cook, we are building our future on Invention, Connection, People, and Community. As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device. Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
