Compliance Officer

Job Purpose

The Compliance Officer is accountable for ensuring that Translumina Medical’s interactions with Healthcare Professionals (HCPs), Healthcare Institutions, Government Officials, and Distributors/Channel Partners are conducted ethically, transparently, and in full conformity with applicable law and industry codes — including the IFPMA Code of Practice, the AdvaMed Code of Ethics, the Uniform Code for Medical Device Marketing Practices (UCMDMP/UCMPMD), the Foreign Corrupt Practices Act (FCPA) where applicable, and India’s Digital Personal Data Protection (DPDP) Act, 2023 and related privacy regulations.

Given the nature of coronary stent commercialization — hospital tenders, cath-lab clinical training, physician proctorship/education programs, government empanelment, and multi-tier distribution — the role holder will build and operate a compliance program specifically calibrated to interventional cardiology commercial practices, anti-bribery/anti-corruption (ABAC) risk in dealings with public healthcare institutions, and lawful handling of patient and physician data.

The role holder will formulate the Code of Conduct, ABAC policy, and HCP/Distributor engagement policies; lead group-wide training and roll-out; and conduct continuous preventive and detective monitoring, partnering with senior management to protect the company’s license to operate and reputation while enabling compliant commercial growth.

Key Responsibilities

Ethical HCP, Institution & Government Engagement

• Design, implement, and monitor policies governing interactions with HCPs and Healthcare Institutions — sponsorships, honoraria, speaker programs, proctorship/training for stent implantation, product evaluations, and continuing medical education — aligned to the IFPMA Code of Practice and AdvaMed Code of Ethics.
• Own the framework for engagement with Government Officials and public healthcare institutions, including tender participation, government hospital empanelment, and regulatory liaison, ensuring no improper inducement occurs at any stage of the sales or registration cycle.
• Maintain a transparency register / HCP spend database (fair market value, caps, approval workflows) and conduct periodic spot-checks against the register.
• Review and pre-approve high-risk engagements (KOL contracts, international proctorship travel, government tenders) above defined risk thresholds.

Anti-Bribery, Anti-Corruption & Third-Party Risk

• Operate the group ABAC program (aligned to FCPA principles for markets with US nexus, and domestic anti-corruption law) covering gifts, hospitality, facilitation payments, and charitable/CSR contributions connected to government or institutional stakeholders.
• Classify distributors, stockists, and channel partners by corruption/compliance risk; conduct risk-based due diligence, contractual compliance clauses, and periodic audits (desk, remote, onsite) of high-risk partners.
• Investigate red flags in distributor conduct (unusual discounting, tender irregularities, unsubstantiated commissions) and drive corrective/disciplinary action.

Privacy & Data Protection

• Ensure compliant collection, processing, and storage of patient, physician, and distributor data (including device registries and post-market clinical follow-up data) under the DPDP Act, 2023 and applicable cross-border transfer requirements.
• Oversee data processing agreements with distributors, hospitals, CROs, and IT vendors; coordinate breach-notification readiness with IT/InfoSec.

Program Governance, Training & Monitoring

• Formulate and maintain the Group Code of Conduct, ABAC Policy, HCP Engagement Policy, Gifts & Hospitality Policy, and Data Privacy Policy; drive periodic review against evolving IFPMA/AdvaMed/UCMDMP/DPDP requirements.
• Design and deliver risk-based training for sales, marketing, clinical affairs, tender/government-liaison, and distribution teams.
• Conduct continuous preventive and detective monitoring (transaction testing, expense audits, tender file reviews) and report findings, trends, and remediation status to senior management and the Board Audit & Risk Committee.
• Manage the internal Speak Up / whistleblower channel — confidential intake, triage, investigation coordination with Legal, HR, and Quality, and tracking of corrective and preventive actions (CAPAs) to closure.
• Advise senior leadership on compliance risk in emerging commercial strategies (new distributor markets, tender models, KOL/proctorship programs) and provide pragmatic, business-enabling guidance.

Job Related Skills

Ethical Judgment & Flexible Thinking

• Quickly grasps interventional cardiology/medtech commercial practices, tender dynamics, and associated compliance risk.
• Evaluates realistic alternatives to compliance gaps and builds pragmatic, risk-calibrated solutions rather than blanket restrictions.
• Collaborates effectively across sales, clinical affairs, regulatory, quality, and finance.

Developing a Compliance Culture

• Embeds behaviours consistent with medtech industry codes (IFPMA, AdvaMed, UCMDMP) and corporate governance norms.
• Builds awareness and ownership of compliance among commercial and clinical teams, not just central enforcement.

Continuous Improvement

• Sets measurable compliance program targets (training completion, audit coverage, CAPA closure) tied to business risk.
• Challenges existing processes to simplify controls while maintaining full regulatory and code adherence.

Stakeholder & Relationship Management

• Works cooperatively with cross-functional and distributor stakeholders while maintaining independence in flagging and stopping improper conduct.
• Maintains a high level of integrity, discretion, and trust when handling sensitive investigations.
• Communicates and escalates effectively to senior management and the Board on compliance risk.

Knowledge and Capabilities Required

• Working knowledge of the IFPMA Code of Practice, AdvaMed Code of Ethics, and the Uniform Code for Medical Device Marketing Practices (UCMDMP/UCMPMD).
• Familiarity with anti-bribery/anti-corruption regimes applicable to medtech (FCPA principles, domestic anti-corruption law) and their application to government tenders and hospital empanelment.
• Working knowledge of India’s DPDP Act, 2023 and its application to patient/physician data and vendor data-processing arrangements.
• Demonstrated experience designing and operating compliance/ABAC programs, third-party risk management, and investigations in a multi-jurisdictional or MNC medtech/pharma setting.
• Strong project management skills to drive multiple compliance initiatives (policy rollout, training, audits) across functions simultaneously.
• Ability to communicate at senior/Board level and influence commercial teams to adopt compliant practices without impeding legitimate business.
• Superior analytical and investigative skills — able to diagnose root causes, resolve conflicts, and design practical remediation.

Basic Requirements

• Bachelor’s or Master’s degree in Law, Business Administration, Life Sciences, or Risk Management.
• 8+ years of experience in Compliance, Ethics, or Risk Management leadership roles, preferably in medtech, pharmaceuticals, or another regulated, multi-jurisdictional/MNC setting.
• Prior exposure to interventional cardiology, medical device tenders, or hospital/government institutional sales environments is an advantage.

Report to:  Managing Director / Group Compliance Officer