Clinical Evaluation Manager

The Clinical Evaluations 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 use our methods to develop and contribute to the improvement of our best practices for performing clinical evaluations and related work.   
 

Job Description:

• Prepare clinical evaluation plans and reports for company products, including searching and analyzing published literature and public safety databases.
• Works cross-functionally to ensure clinical evaluations are integrated with other company-sponsored clinical trials, risk management, and other stakeholders.
• Oversees schedule for performing clinical evaluations and related work for products.
• Ensures clinical evaluation plans and reports are available to support product launch and audit schedules.
• Effectively responds to questions from auditors during audits.
• Plans and supports post-market clinical follow-up studies including managing data from internal and external sources such as disease-site-specific and device-specific registries.
• Performs all required management responsibilities including but not limited to: implementing company policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing the business; and maintaining functional, technical, and external market awareness necessary for managing the immediate organization. 

Skills, Experience, and Qualifications:

ESSENTIAL (minimal requirements for interview):

• Good understanding of MDR regulations.
• Strong ability to explain, influence and advocate (both in writing and in person) to advance the company’s 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. 
• Typical experience: Master’s degree with experience in clinical evaluations experience or Ph.D. in an oncology-related field with a strong publication and technical writing background

DESIRABLE (Not essential, but highly advantageous):

• Ph.D. in radiation oncology or interventional oncology
• Experience writing Clinical Evaluation Reports (EU MDR)
• Experience with Medical Device Audits
• Experience working with global teams.
• Comfortable communicating with customers as well as internal stakeholders.
• Interest in career advancement