Key Responsibilities:
* Develop and implement regulatory strategies for new product development and post-market activities
* Manage global submissions and registrations of medical devices
* Act as the primary point of contact for regulatory agencies worldwide
* Monitor and apply evolving regulatory requirements to ensure company compliance
Candidate Requirements:
* Bachelor's degree in a relevant field, such as Engineering or Life Sciences
* 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership role
* In-depth knowledge of US FDA and EU medical device regulations, including MDR guidelines
* Excellent organizational, leadership, and communication skills
Benefits:
* Opportunity to work on high-profile projects
* Collaborative and dynamic work environment
* Professional growth and development opportunities