Job Description

SUMMARY

As a Regulatory Compliance Specialist, you are required to oversee compliance with FDA, ISO, and EU regulations. Develop and implement strategies, conduct audits, and produce quality documentation. Furthermore, provides recommendations for improvement, tracks metrics, and maintains confidential records.

ABOUT US

Wadhwani AI is a nonprofit institute building and deploying applied AI solutions to solve critical issues in public health, agriculture, education, and urban development in underserved communities in the global south. We collaborate with governments, social sector organizations, academic and research institutions, and domain experts to identify real-world problems and develop practical AI solutions to tackle these issues to make a substantial positive impact.

We have over 30+ AI projects supported by leading philanthropies such as the Bill & Melinda Gates Foundation, USAID, and Google.org. With a team of over 200 professionals, our expertise encompasses AI/ML research and innovation, software engineering, domain knowledge, design, and user research.

In the Press:

Cultures page of Wadhwani AI -

ROLES AND RESPONSIBILITIES

Stay updated and understand relevant FDA, ISO, and EU regulatory requirements as applicable to the organization.

Interpret and communicate regulatory requirements to internal teams to ensure compliance.

Develop strategies and procedures to align company practices with regulatory requirements.

Collaborate with various departments to implement necessary changes to achieve compliance.

Develop and produce high-quality documentation, including manuals, guides, reports, and procedures, in compliance with regulatory requirements

Conduct regular audits to assess compliance levels and identify areas for improvement.

Assist in the preparation of regulatory submissions and responses to queries or audits

Analyze data and reports to track compliance metrics and trends.

Provide recommendations and corrective actions to resolve non-compliance issues.

Maintain accurate and up-to-date documentation of compliance activities.

Prepare reports summarizing compliance status, findings, and recommendations for management.

Function with utmost sensitivity towards data confidentiality and privacy.

Expect up to 25% of the time for other activities as per the competency of the candidate and need in the organization

Perform duties as assigned by the supervisor from time to time.

QUALIFICATION AND EXPERIENCE

Master\'s degree in a relevant field (e.g., Business Administration, regulatory affairs, Quality Management).

Certification in ISO standards (e.g.,ISO 9001, ISO 13485) is highly desirable.

Proven experience of 3-4 years in implementing and managing regulatory compliance within FDA/EU/ISO regulatory frameworks.

ISO compliance within an organization.

REQUIREMENTS

In-depth knowledge of FDA, ISO, and EU regulations and guidelines as applicable to the healthcare industry.

Proven effectiveness while working in a team-based environment, but capable also of working independently.

Proficient computer skills in Microsoft Office Suite applications, including Word, Excel, PowerPoint, and Outlook.

Excellent communication and interpersonal skills and ability to work effectively in a complex environment.

Comfort with collaborating across all levels of leadership internally and externally.

Skilled in successfully working with geographically dispersed teams and working in a multicultural environment.

Detail-oriented with a focus on accuracy and compliance documentation.

Ability to travel as required.

Wadhwani AI