Job Description:
· Biocompatibility assessment and organization of respective testing for medical devices
· Supporting resolution of biological evaluation issues for current manufacturing facilities and for new product development
· Internal technical document creation and approval
· Supporting Complaints investigations, CAPAs, and other general technical support duties required within the team
· Creating Technical Reviews, specifications and other mandatory documents for regulatory submissions
· Reviewing and preparing of procedures to keep pace with standards development
· Representing the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
· Helping in development and generating material for staff training and data presentations
· Maintaining relevant scientific and medical knowledge by attending conferences, courses and meetings
· Educating internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization.
· Providing support for key opinion leaders
Required Skillset(s):
· Competency as subject matter expert in biocompatibility domain
· Working knowledge of analytical chemistry
· Has a comprehensive record of external training in area of competence
· Prior experience with risk assessment of manufacturing materials
· Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter.
· Has experience in conveying complex scientific topics in a clear and comprehensible fashion.
· Strong problem-solving skills.
· Knowledge/Experience in dealing with Polymers and their biocompatibility
· Experience in medical device research -Orthopaedic, dental, Spine industry