Lead Product Regulator

3 weeks ago


massachusetts, United States HCL Technologies Full time

Job FamilyDelivery Enablement No. of Positions1Job Description (Posting). 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 (1.) 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 regulations (2.) 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 (3.) To audit the assigned product's technical documents validating product regulatory compliance as per the markets' laws and norms and suggest modifications when required (4.) 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 (5.) 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 (6.) To ensure that necessary support post release of the product for customers and clients is provided by the team and suggest modifications/updations as requiredEmployee GroupBusiness Line FT CityOthersEntityCSWAuto req ID1491366BRExpected Date of Closure20-Jan-2025Skill (Primary)Tools and Standards (ERS)-HW Product Dev Process Standard-Medical - ISO13485 Process Skill Level 3 (Secondary Skill 1)Quality Management Skills (ERS)-Domain Process-MQMS Location: Massachusetts Country: USA



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