
Lead Product Regulator
About the role
Job Summary
To effectively guide the team in implementing product regulatory standards & compliances for assigned client product requirements and audit the same as per the target markets' product/ government laws
Key Responsibilities
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To independently identify & implement product standards and regulatory requirements (with the cross functional product development teams) in compliance to target market/country's product compliance regulationsÂ
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To lead the product design discussions pertaining to 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
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To audit the assigned product's technical documents validating product regulatory compliance as per the markets' laws and norms and suggest modifications when required
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To participate in product standards and regulations compliance internal audits/reviews of the assigned product and make necessary modifications as required; and, also participate in accredited external Compliance test audits for each of the identified product's target market
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To effectively guide team in completing assigned tasks in adherence to project timelines and mentor them to provide first-time-right regulatory and product standards deliverables
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To ensure that necessary support post release of the product for customers and clients is provided by the team and suggest modifications/updations as required
Skill Requirements
Labelling requirement for IVDR compliance
Other Requirements
null
Required skills
regulatory compliance
product compliance
documentation
audit support
stakeholder management
About HCL Technologies
Baltimore
Headquarters