Product Regulatory Analyst

Job Summary

To independently identify and support the implementation of product regulatory standards & compliances for assigned client product requirements as per the target markets' product/ government laws

Key Responsibilities

1. To identify & independently implement product standards and regulatory requirements (with the cross functional product development teams) in compliance to target market/country's product compliance regulationsÂ

2. To participate in product design discussions (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 prepare the assigned product's technical documents validating product regulatory compliance as per the markets' laws and norms

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 provide necessary support post release of the product for customers and clients and make any regulatory modifications as suggested by supervisor

Skill Requirements

The skill requirements are to have knowledge and experience in IVDR regulation. Any working experience with IVD products are good to have skill.

Other Requirements

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