Clinical Evaluations Manager

The Clinical & Collaborations Manager will oversee the direction, planning, and execution of performing clinical evaluations and related work according to the EU Medical Device Regulation requirements. The person in this role will establish best practices and procedures for performing clinical evaluations and related work.     

Additional duties to include:  

• Prepare clinical evaluation plans and reports for products, including searching and analyzing published literature and public safety databases.
• Works cross-functionally to ensure clinical evaluations are integrated with risk management and other areas.
• Oversees schedule for performing clinical evaluations and related work for products.
• Ensures clinical evaluation reports and related documents are available to support product launch and audit schedules.
• Effectively responds to questions from auditors during audits.
• Manages responses to audit reports.
• Performs all required management responsibilities including but not limited to implementing policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing business; and maintaining functional, technical, and external market awareness necessary for managing an immediate organization.     

Minimum Required Skills and Knowledge:

• Strong ability to explain, persuade and advocate (both in writing and in person) to advance Company goals
• Strong project management and organizational skills.
• Strong verbal and written skills.
• Strong interpersonal and teamwork skills
• Research, medical, or technical background
• Experience with radiation therapy and/or oncology.
• Experience within the medical device industry.  

 Other Desired Skills and Knowledge:  

• Obtains and completes LMS training plan specific to assigned responsibility
• Proficient in utilizing business tools such as E-mail, MS Word, Excel, and PowerPoint 
• Typical Certification and Training
• Ph.D. or MD