Lead Product Regulator
United States
Job Description
Lead Product Regulator
Baltimore, Maryland

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

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 required

Skill Requirements

Labelling requirement for IVDR compliance 

Other Requirements

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Maximum Salary (US):  97000
Minimum Salary (US):  64000
Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 226,300 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending December 2025 totaled $14.5 billion.

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.