Responsibilities

• Compile information for regulatory submissions – EU MDR and APAC focused
• Manage ongoing submissions and any requests for more information from regulatory agencies (i.e., Notified Body)
• Conduct research on regulatory or scientific issues as required
• Identify product class and assist in developing regulatory strategy
• Assist with literature search and summary related to product type and submissions
• Assist in developing overall regulatory strategy
• Conduct research on regulatory issues as required
• Perform literature reviews
• Identify product classification and assist in developing regulatory assessments and strategy, SOPs and WIs, registration and listings under direction of leader.
• Compile, write and/or submit regulatory submissions under direction of leader
• Summarize testing reports for submissions
• Identify and interpret relevant standards and guidance documents
• Participate in regulatory agency meetings with leader

Qualifications And Skills

• Bachelor’s or Advanced Degree (Masters or PHD) in a related field
• Minimum of 5 years of relevant medical device experience
• Written, verbal communication and interpersonal skills
• Current, working knowledge of medical device regulations and/or biologics regulations, i.e., US FDA 21 CFR, European regulations (i.e., MDD/MDR), Health Canada, 21 CFR 820, ISO 13485, MDSAP, other global regulations and standards as relates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)

General Requirements

• Excellent spoken and written English and Chinese, (Mandarin and Cantonese)
• Excellent computer literacy, good interpersonal and presentation skills
• Good team player with high degree of integrity and responsibility
• Career minded self-starter with initiative and the ability to work under pressure
• Outgoing, hardworking, and positive working attitude
• Occasional travel to Shenzhen, Beijing facilities is required
• Experience with medical robotics products would be a great benefit
• Experience in clinical investigations is preferred
• Write and review complex documents

All applications applied through our system will be delivered directly to the advertiser and privacy of personal data of the applicant will be ensured with security.