Senior Director, Legal & Compliance
2 days ago
Clamart
Responsibilities Commercial & Contractual Legal Support • Draft, review, and negotiate a wide range of agreements — NDAs, supply and distribution agreements, service contracts, licensing arrangements, advisory board agreements, market access agreements, and procurement contracts, • Provide first-line legal support to sales, business development, and commercial teams across EU markets, • Manage relationships with external counsel for litigation, disputes, and specialist matters, • Build processes to ensure a more sound CLM system and legal ops frameworks. Regulatory & Compliance • Ensure ongoing compliance with EU MDR/IVDR and applicable local healthcare regulations across CardioFlow's EU operating footprint, • Maintain and update the compliance framework — policies, procedures, training, and escalation mechanisms, • Act as the local interface with regulatory bodies and support quality/regulatory teams on legal questions, • Support data protection compliance (GDPR) in coordination with the Group DPO — see Privacy section below Corporate Governance • Lead corporate life management for CardioFlow's legal entities — board governance, shareholder matters, KYC/AML, and statutory filings, • Ensure compliance with HKEX listing obligations and applicable corporate law requirements in coordination with Group Legal, • Maintain representation frameworks and delegations of authority Business Partnership • Serve as a trusted legal advisor to the CardioFlow CEO and executive team on transactional, commercial, and risk matters, • Structure business initiatives to align with legal, regulatory, and compliance requirements Compliance & Process Improvement Drive continuous improvement of legal and compliance processes — including contract templates, approval workflows, compliance calendars, and escalation frameworks — ensuring alignment with Group Legal standards and scalability as the business grows. IP & Innovation • Collaborate with the MicroPort HQ IP team to implement IP strategies and patent portfolio management plans for CardioFlow, • Oversee and support the local IP portfolio — including patent filings, renewals, freedom-to-operate analyses, and IP due diligence on partnerships and transactions, • Advise on IP aspects of commercial agreements, R&D partnerships, licensing arrangements, and technology transfers Privacy • Oversee data protection compliance (GDPR and applicable local privacy laws) in coordination with the DPO Team Leadership • Manage and develop a team of 5 legal professionals across EU and China, coordinating workload distribution, performance development, and capability building, • Oversee external counsel relationships and manage legal spend effectively, • Foster a collaborative legal function that operates as a genuine business partner across CardioFlow's international structure Qualifications & Experience • Minimum 8 years of post-qualification legal experience, ideally in MedTech, medical devices or a regulated life sciences environment (in-house or law firm, both is a plus), • Experience managing a legal team including across geographies, • Previous experience advising and presenting complex matters to executives and/or board-level stakeholders is a strong advantage, • Solid understanding of EU MDR/IVDR and European healthcare regulatory frameworks; knowledge of another EU jurisdiction (preferably Italian) is a strong advantage, • Proven track record in contracting MedTech related deals (distributors, suppliers, procurement, sales, …) across EU and international counterparties, • Comfortable operating in a matrix structure — able to work autonomously at subsidiary level while aligning and collaborating with Group-level direction, • Strong generalist profile: corporate governance, contracts, litigation, compliance, data protection, IP and regulatory interface, • Excellent English (written and oral, including legal drafting) and French, an additional European language (preferably Italian) is a plus, • Master's degree (Bac+5) in law or equivalent; bar admission in France is a strong advantage, • Sharp analytical and communication skills — able to translate legal complexity into clear business guidance., • Business mindset, agile, pragmatic and constructive attitude are a strong plus.