Job Details

ID #44697896
State California
City Milpitas
Job type Contract
Salary USD Depends on Experience Depends on Experience
Source Cynet Systems
Showed 2022-08-08
Date 2022-08-05
Deadline 2022-10-04
Category Et cetera
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EU-MDR Lead

California, Milpitas, 95035 Milpitas USA

Vacancy expired!

We are looking for

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.

Qualifications:
  • 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!

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