POSITION DESCRIPTION
The Scientist/Senior Scientist will provide an advanced technical expertise in biocompatibility assessment for Greater China R&D organization. He /she will manage the biological safety compliance process according to ISO, AAMI, GB, YY, and other country specific regulatory policies, guidelines, and procedures. He/she will assess material safety, conduct biocompatibility assessments, develop biocompatibility test strategy, select test methods, interpret results, solve technical issues, and address questions from regulatory agencies. He/she will conduct biocompatibility evaluation to support product development programs, regulatory submissions, process changes, and quality control procedures. He/she will serve as a liaison with Medtronic’s biocompatibility/toxicology experts internally, and between standard organizations, industry peers, government laboratories, and research institutions to contribute on biological safety standard development externally.

POSITION RESPONSIBILITIES
61 Be responsible for planning, initiating, and executing device biological safety evaluation through medical device during material scouting, product development, and regulatory submission process.
61 Serve as a biological safety liaison between global product development teams. Provide guidance for testing related to new investigational and strategic device development programs during PDP. Provide professional advices and interpretations on regulatory requirements related to medical device submissions for all divisions.
61 Develop plans, reports, conduct trouble shooting, and interpret test outcome of biological safety testing, bioanalytical and chemical characterization data to determine if device safety is sufficiently addressed.
61 Ensure biological safety compliance of products developed at China R&D according to ISO 10993, GB/T 16886 standards, country specific policies, regulations, and guidelines (US FDA, EU, Japan, and China).
61 Evaluate biocompatibility and toxicological contract research organizations globally, screen vendors to meet different business purposes. Conduct technical audits at CROs.
61 Draft SOPs and other supportive documents as needed to provide directory and guidance on device safety assessment.
61 Complete other assigned research tasks assigned by management.

BASIC QUALIFICATIONS
61 Ph. D. or M. S. with an advanced degree in biology, toxicology, pharmacology, biochemistry, molecular biology or other related biological sciences
61 Speak and write English fluently
61 Excellent interpersonal, written and verbal communication skills to deal with team members and other functions to accomplish goals and objectives
61 Self-driven and has the ability to work efficiently in a cross-cultural environment
61 Be able to travel up to 5% of the time

DESIRED/PREFERRED QUALIFICATIONS
61 Oversea research experiences
61 Experiences with GLP studies
61 Knowledge of ISO 10993, GB/T 16886, or related industry standards
61 Relevant experiences in regulated industries such as medical device, pharmaceutical, and contract research organizations
61 Led research project
61 Publications in English