30 Sep
|
Avana Medical
|
Chennai
30 Sep
Avana Medical
Chennai
AVANA GROUP
Head — Legal & Compliance Group Legal, Ethics & Compliance, and Regulatory Oversight
Position title : Manager — Legal & Compliance
Function : Legal, Ethics & Compliance, Regulatory Oversight
Location : Chennai (Corporate Office), with travel across India and SAARC territories
Reports to : Managing Director
Functional reporting : Principal Compliance functions —for compliance matters
Direct reports : Regulatory Affairs Executive(s); Compliance Coordinator (as the function grows)
Interfaces
1. POSITION PURPOSE To own Avana Group’s legal and compliance framework as a single accountable function — protecting the Group’s principal relationships, its licences and its reputation — by ensuring that every engagement with sub-distributors, healthcare professionals, institutions and government bodies is conducted in accordance with the compliance requirements of Avana’s principals and all applicable Indian law.
The role carries a specific mandate to act as Avana’s designated compliance point of contact for its principals, including the Arthrex India Compliance Officer responsibilities, and to exercise independent judgement in that capacity.
2. KEY RESPONSIBILITY AREAS
A. Ethics & Compliance (approx. 40% of role)
- Own, maintain and periodically update the Group compliance framework — the Code of Conduct, anti-bribery and anti-corruption policy, gifts and hospitality policy, conflict of interest policy, and the speak-up / whistleblower channel — aligned to the compliance codes of each principal.
- Run the sub-distributor onboarding gate end to end: due diligence, background and reference checks, preparation of the due diligence pack, submission to the relevant principal’s compliance team, and tracking of written approval. No sub-distributor is appointed or activated without a documented approval on file.
- Maintain the sub-distributor and third-party register, including approval status, agreement status, training status and renewal dates.
- Design and deliver the annual compliance training programme for Avana employees and sub-distributor personnel; maintain attendance records, assessment outcomes and certificates, and furnish them to principals on request.
- Review and transparent healthcare professional (HCP)
engagements — sponsorships, speaker and faculty arrangements, key opinion leader programmes such as Margdarshan, grants, educational support, demonstration equipment and product samples — against principal codes, the Uniform Code for Medical Device Marketing Practices (UCMDMP) and the Prevention of Corruption Act, 1988.
- Conduct or commission internal investigations into compliance concerns; document findings and recommend disciplinary or contractual action.
- Serve as the interface for compliance audits and reviews conducted by principals, and drive closure of audit findings within agreed timelines.
B. Legal (approx. 30% of role)
- Draft, review and negotiate the Group’s contracts: sub-distribution and dealer agreements, employment and consultancy contracts, vendor and service agreements, non-disclosure agreements, leases, and tender and institutional supply documentation.
- Build and maintain a contract template library and negotiation playbook so that standard agreements do not require external counsel.
- Manage litigation, disputes, statutory notices and legal recovery actions; appoint, brief and control external counsel and manage the legal budget.
- Advise the business on commercial risk — credit and security arrangements, limitation of liability, indemnities, termination exposure and channel disputes.
- Coordinate corporate secretarial, trademark and intellectual property matters with external advisors.
C. Regulatory oversight (approx. 20% of role)
- Provide oversight — not day-to-day execution — of the Group’s Central Drugs Standard Control Organisation (CDSCO) portfolio: import licences (Form MD-14 / MD-15), registrations, device grouping submissions, post-approval change (PAC) applications, labelling and Medical Devices Rules, 2017 (MDR 2017) obligations.
- Ensure Avana discharges its obligations as Authorised Indian Agent for its principals,
including record-keeping, distribution traceability and communication with the licensing authority.
- Own the recall, field safety corrective action and materiovigilance (Materiovigilance Programme of India, MvPI) processes, including adverse event reporting timelines.
- Maintain the licence and registration calendar so that no licence, registration or renewal lapses.
D. Governance & reporting (approx. 10% of role)
- Maintain a Group compliance risk register with owners, mitigation actions and review dates.
- Submit a quarterly compliance report to the Managing Director covering onboarding activity, training completion, open investigations, audit findings and regulatory status; share the applicable extract with each principal.
- Support the independent Compliance Auditor (see Annexure A) with records access and remediation tracking.
5. PERSON SPECIFICATION
Qualifications
- Bachelor of Laws (LL.B.) from a recognised university; a postgraduate qualification in law, or a certification in compliance or forensic practice, is an advantage.
- Enrolment with a Bar Council of India state bar is preferred
Experience
- 3 to 5 years post-qualification experience, of which at least 3 years in a compliance or legal role within medical devices, pharmaceuticals, or a comparable regulated distribution business.
- Direct exposure to a multinational principal’s compliance regime — for example a medical device or pharmaceutical multinational, or a Big Four / forensic advisory compliance practice — is strongly preferred over general corporate legal experience.
- Demonstrated experience of third-party due diligence and channel-partner onboarding.
Knowledge
- Medical Devices Rules, 2017 and CDSCO licensing practice; Authorised Indian Agent obligations.
- Prevention of Corruption Act, 1988; the Uniform Code for Medical Device Marketing Practices (UCMDMP); working familiarity with the United States Foreign Corrupt Practices Act (FCPA) and the United Kingdom Bribery Act, given Avana’s United States and European principals.
- Indian Contract Act, Companies Act, employment and labour law fundamentals; Goods and Services Tax and customs implications of import distribution at an advisory level.
📌 Legal Manager (Chennai)
🏢 Avana Medical
📍 Chennai