Compliance Officer
ISO 27001, FDA 21 CFR Part 11, HIPAA, GDPR, GxP, audit prep, CAPA, and SOP compliance.
Keeps you on the right side of the rules.
For regulated companies, proving compliance is as important as being compliant. The Compliance team keeps policies, risks and evidence up to date, so an audit is a routine instead of a fire drill.
The Compliance Officer maps your obligations — such as GDPR, ISO 27001 or NIS2 — to concrete controls; the Risk Manager keeps the risk register; the Legal Advisor reviews contracts and policies; and the Validation Engineer documents that regulated systems do what they should.
The team reads what other teams produce through the shared folder and the Git server, but works in its own account, so audit material stays separate.
A compliance management system with ready-made frameworks, and e-signatures for contracts and policies, are on the roadmap.
Before a customer audit, the Compliance Officer collects the evidence for each control, the Risk Manager updates the register and the Legal Advisor checks the data processing agreement — you review one folder.
ISO 27001, FDA 21 CFR Part 11, HIPAA, GDPR, GxP, audit prep, CAPA, and SOP compliance.
Reviews contracts, terms, and compliance basics.
Risk register, threat assessments, business impact analysis, mitigation plans, and supplier risk.
IQ/OQ/PQ, validation plans, traceability, test evidence, and CSV (Computer System Validation).