Compliance Manager

Role & responsibilities

1. Develop and maintain Validation Master Plan (VMP), User Requirement Specification (URS), Design / Functional / Test Specifications (DS, FS, TS), and Traceability Matrices.
2. Plan and execute IQ / OQ / PQ testing for software and connected IoT systems.
3. Perform risk-based validation aligned to GAMP 5 methodology.
4. Collaborate with engineering to ensure validation evidence is built into DevOps pipelines.
5. Implement and monitor controls for 21 CFR Part 11, Annex 11, and GxP-compliant systems (electronic signatures, audit trails, access control, backup, change management).
6. Conduct periodic data-integrity audits and support client inspections.
7. Provide compliance training to development, QA, and operations teams.
8. Define and monitor security, availability, and confidentiality controls for SOC 2 readiness.
9. Maintain ISMS documentation, perform risk assessments, and coordinate internal audits.
10. Create and update Standard Operating Procedures (SOPs), Work Instructions (WIs), and CAPA logs.
11. Identify the right candidates in various airlines and work with them in getting airlines approvals for Mindlabs devices
12. Identify appropriate vendors for CE, FCC certifications and get Mindlabs devices certified.
13. Work with customers in handling compliance related queries and executing the same.

Preferred candidate profile

1. At least 2 years experience in 21 CFR Part 11, GxP and GAMP 5 frameworks.
2. At least 2 years experience in implementing CSV validation
3. Good understanding of SOC2, ISO 27001 (ISMS), GDPR / Data-integrity principles
4. Exceptional documentation skills, attention to detail, cross-team communication, audit presentation, training delivery