Minimum Requirements
Bachelors degree required
Minimum of 10 years of Clinical Research experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of Clinical Research experience with 7+ years of managerial experience
Nice to Have
EDUCATION
Bachelor’s degree in engineering, physical/ biological sciences, or related medical/scientific field.
Master’s degree of PhD desireable
JOB EXPERIENCE
• 10 years clinical research experience in a medical device or related industry
• Experience interacting with the FDA and other regulatory bodies through the full process of new product approvals
• Experience at working with Class III (implantable) devices at all stages from concept through market released product
• Seven + years in medical device industry. Seven + years in role of managing clinical studies of Class III (permanently implantable) devices
• Previous experience conducting multiple post market approval / post market surveillance studies
SKILLS/COMPETENCIES
• Leadership skills
• Influence management skills
• Strategic planning experience
• Results orientation – strong planning/execution skills
• Demonstrated expertise in managing clinical studies and regulatory programs.
• Proven project management and problem solving skills
• Working knowledge of statistics, statistical methodology, and application of statistics in scientific / medical research
• Demonstrated high proficiency in the following areas: Shaping strategy Building networks & relationships Attracting, developing & retaining top talent
• Previous successful completion of multiple clinical studies including successful interaction with the FDA through product approval.
• Eight plus years proven track record of building and leading high-performance teams.
• Experience working with Cardiac Surgeons
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)