In this role, you have the opportunity to
Be an integral part of the defibrillator Monitor development team and have the opportunity to work with the group of world-class, Regulatory and standard Engineers who develop products that help save lives all over the world.
You are responsible for
Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards
Review development quality reports and plans to ensure that the information required for submissions is adequate
Plan, generate, and coordinate regulatory submissions for product/solution licensing
Coordinate testing required to support regulatory submissions
Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)
Maintain existing regulatory fillings/licenses, managing updates and related change control processes.
Assist with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
Advise product design teams on regulatory strategy and requirements for specific new product introductions and product changes, and assist in maintaining regulatory compliance
Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registration such as CE marking, CFDA, FDA and clinical evaluations
Develops and facilitates regulatory submissions, for new products/solution, existing products/solutions
Reviews and validates marketing and labeling materials.
Product standard compliance testing and release reports.
Provide technical support in regulation and standard related field, help product register smoothly
You are a part of
To succeed in this role, you should have the following skills and experience
The successful candidate will possess the following knowledge, skills education and experience:
B.S. Degree in Engineering. M.S. Degree preferred
3-5 years of experience in the medical device industry
Must have experience with successful preparation of CFDA, CE, or FDA international documents
Some experience in Design Controls
Working knowledge of medical device regulations (21 CFR), FDA law, MDD, MDR, other global laws and regulations.
Experience in medical IEC/ISO standards
Ability to effectively communicate complex matters in simply understood terms, both verbally and in writing
Self-starter and innovative thinker
Strong ability of writing the report of issue analysis and presenting the report in team with English