Global Regulatory Affairs Specialist II

Cook Group; Vandergrift (Westmoreland County); Sur place; USD 80 000 - 100 000; Plein temps

Résumé du poste

Cook Group is seeking a Regulatory Affairs Specialist II to plan and prepare submissions for regulatory approvals of medical devices in specified markets. You will develop regulatory strategies, maintain approvals, and act as a liaison between Cook and local offices/distributors.

The role requires knowledge of global medical device regulations, strong documentation skills, and the ability to manage multiple tasks to meet deadlines. Travel may be required.

Qualifications

• Proficient reading, writing and speaking English.
• Bachelor’s degree in a relevant technical or scientific discipline.
• Knowledge of medical device quality standards and regulatory requirements.
• 3 years of experience in the medical device industry.
• Working knowledge of Microsoft Office.

Responsabilités

• Plan and prepare regulatory submissions for medical devices in target markets.
• Develop regulatory strategies and maintain approvals and re-registrations.
• Serve as liaison between Cook manufacturer and Local Office/Distributor.
• Create and organize technical documentation and maintain registrations.
• Support post-market regulatory activities and lifecycle changes.

Connaissances

English proficiency

Regulatory knowledge

Problem solving

Communication skills

Multitasking

Formation

Bachelor's degree in technical or scientific field

Outils

Microsoft Office

Description du poste

Cook Group is seeking a Regulatory Affairs Specialist II to plan and prepare submissions for regulatory approvals of medical devices in specified markets. You will develop regulatory strategies, maintain approvals, and act as a liaison between Cook and local offices/distributors.

The role requires knowledge of global medical device regulations, strong documentation skills, and the ability to manage multiple tasks to meet deadlines. Travel may be required.