Regulatory Affairs Specialist

Why Join Us

Are you looking for a meaningful career in medical devices?

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.

Overview

The 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.

Qualifications

• 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.

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