- Maintaining a deep understanding of new and existing regulations that may impact their organization’s products and processes.
- Using that understanding to standardize all business operations and establish clear, documented protocols.
- Explaining regulations, procedures, and policies to all employees and stakeholders as necessary.
- Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency.
- Reviewing marketing, legal, and technical documentation (including case files and clinical research reports) to assess compliance.
- Recommending courses of remediation to help their company achieve the necessary levels of compliance.
- Implementing internal audits of products and protocols to identify areas of weakness, and putting in place corrective measures.
- Regularly reporting on compliance status and measures to both internal and external parties.
- Preparing for and facilitating third-party audits as necessary.
- Acting as liaisons between their organization and state, local, federal, and international agencies to submit required forms and paperwork.
In addition to the responsibilities listed above, regulatory specialists are often leveraged at various stages throughout the product development process to ensure compliance every step of the way, from research and development through manufacturing, marketing, and final approval
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
