Senior Standard Compliance Engineer

Philips (Shenzhen, 中国) 20天前发布

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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

  • The Senior Standard Compliance Engineer will be one member of the V&V team in our defibrillator Monitor development group within the ECR Business Innovation Unit (BIU)

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


Senior Standard Compliance Engineer

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