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

Das ist der Job

You will share knowledge and coach colleagues across Regulatory Affairs and related functions.

Darum lohnt es sich

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.

Who You Are • MSc or higher in Life Science or a related discipline (PhD preferred). • 10 to 15 years in medical‑device regulatory affairs with at least 5 years of recent experience on active‑implantable devices. • Proven track record in IDE/510(k)/PMA filings, eSTAR processes, and quality systems application (ISO 13485, software validation, human factors, design verification/validation). • Strong understanding of clinical development, trial design, and regulatory frameworks (ICH, GCP, ISO 14155, EU‑MDR, MPDG, MDCG). • Demonstrated ability to build and execute global regulatory strategy, including EU and US submissions; experience with global dossiers is strongly preferred. • Proven capability to engage health authorities through scientific advice meetings and serve as a credible, influential spokesperson. • Solid knowledge of EU/US regulatory frameworks for medical devices and combination products (QMS, MDSAP, ISO 13485, MDCG guidelines). • Excellent collaboration and communication within multidisciplinary teams and across functions. • Ability to lead and prioritize in a global, matrixed environment and work autonomously. • Fluency in English is mandatory.

Your Role 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 author, oversee, and review device documentation for HA submissions, applying global regulatory strategies, standards, and guidelines.

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. This position is based in Germany.

What We Offer We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!