Director, Regulatory Lead - Medical Device - Bioelectronics (all genders)

We are seeking an experienced Global Regulatory Lead to drive the regulatory strategy for our class III implantable neurostimulation devices focused on Vegus nerve stimulation within our Company's portfolio. You will define, develop, and lead global regulatory strategies for clinical investigations and submissions to achieve approvals for active implantable medical devices. You will prepare and lead health authority interactions, including FDA, Notified Bodies, and EMA advisory groups, building productive relationships to secure favorable regulatory outcomes worldwide. You will act as a key member and sole GRA representative for Governance meetings, guiding the Global Regulatory Affairs Strategy Team to ensure a unified regulatory voice. You will author, oversee, and review device documentation for HA submissions, applying global regulatory strategies, standards, and guidelines. You will share knowledge and coach colleagues across Regulatory Affairs and related functions. You will participate in audits in accordance with QMS ISO 13485 and 21 CFR 820 to maintain ongoing compliance. You will identify opportunities to build trust and scientific credibility with internal and external stakeholders, accelerating development through early engagement. You will work effectively within a matrixed organization to deliver an aligned and successful regulatory strategy. You will demonstrate fluency in English and lead with a collaborative, cross-functional mindset to achieve regulatory milestones.

Key selling points include the opportunity to shape the regulatory pathway for cutting-edge implantable neurostimulation technology, direct interaction with major health authorities, and a leadership role that influences a global regulatory voice within a high-impact portfolio.

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