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EU-MDR Lead for our client in Milpitas, CA Job Title: EU-MDR Lead Job Location: Milpitas, CA Job Type: Contract Job Description: Responsibility:- To independently identify & implement product standards and regulatory requirements (with the cross-functional product development teams) in compliance with the target market/country's product compliance regulations.
- To lead the product design discussions about standards compliance (pre-design and post-implementation phase of the product) with cross-functional development teams to ensure that all product global standards and product regulatory compliances are incorporated and strictly adhered to.
- To audit the assigned product's technical documents validating product regulatory compliance as per the markets' laws and norms and suggest modifications when required.
- To participate in product standards and regulations compliance internal audits/reviews of the assigned product and make necessary modifications as required; and participate in accredited external Compliance test audits for each of the identified product's target market.
- To ensure that necessary support post release of the product for customers and clients is provided by the team and suggest modifications/updates as required.
- To coordinate with customers for reviews and approval processes.
- Good exposure to EU MDD/EUMDR regulatory requirements.
- Hands-on experience in technical file documentation.
- Knowledge of the change management process.
- Experience in PLM tools like Agile/Windchill/Adaptiv.
- Proven medical device background knowledge.
Vacancy expired!