Preferred Skillset(s) :
- Knowledge/Experience in dealing with Polymers and their biocompatibility (Good to have)
- Experience in medical device research (Orthopaedic industry preferred)
Roles and Responsibility :
- 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
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.
The 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 leaders
Job Types: Full-time, Contract
Salary: $70.00 - $90.00 per hour
Schedule:
- 8 hour shift
Work Location: Remote
Company:madagoni LLcLocation:- - USJob Types:Full TimePost Date:June 2, 2022Valid Through:July 2, 2022Est. Salary:USD 70 - 90 / HOUR