EU MDR Program Director
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DESIRED/PREFERRED QUALIFICATIONS
• Proven experience with strategy development, critical thinking and regulation interpretation supporting the commercialization of high-risk permanent implantable devices.
• Expertise in project management and negotiations with global regulators
• Strong organization skills with ability to manage multiple projects simultaneously.
• Ability to lead by influence across a large matrix organization
• Strong analytical abilities coupled with creative problem solving skills.
• Advanced degree in Engineering, Regulatory Science, Life Sciences or related medical/scientific field, or MBA.
• Excellent oral and written communication skills; effective interpersonal and influence skills
• Comfortable with minimal supervision while maintaining good communication.
• Ability to travel up to 25% time.
• History of working collaboratively across functions and geographies
• Proven ability to comprehend principles of regulation, quality systems, portfolio rationalization and medical device operations
• Expertise in global quality system requirements
• Experience working cross-culturally.
PHYSICAL JOB REQUIREMENTS:
• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
