Biocomp SME - Junior & Senior

Open positions# 5The candidate shall be responsible for:• 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 leadersRequired 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 (Good to have)
• Experience in medical device research (Orthopaedic industry preferred)

• Able to effectively resolve conflict between two or more parties
• Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
• Goes beyond existing knowledge base and expands our understanding, methods, and procedures, leaving a base for others to utilize and build upon (trailblazing)
• Demonstrates ability to balance needs of all departments to meet customer expectations and project schedules
• Demonstrates an ability to utilize resources efficiently
• Demonstrated ability to represent the company to accomplish objectives even during disagreements
• Is professional, concise, and sensitive in accomplishing objectives.
• Is able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable
• Demonstrates strong written and verbal communication skills including presentation skills.
• Has ability to tailor the information to the audience and answer with confidence and authority scientific questions
• Handles discussions of complex topics with confidence
• Demonstrates ability to discuss sensitive information with and tailor communication style to listeners’ perspectives, including management, surgeons, and external contacts
• Shows leadership skills and initiative