Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)

Das ist der Job

Overview Work Your Magic with us!

Darum lohnt es sich

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

You will serve as the Device Regulatory Lead within a cross-functional regulatory strategy team, working in close partnership with CMC, device engineering, and quality colleagues to ensure compliant, timely, and scientifically credible submissions to health authorities worldwide.

You bring 10 or more years of regulatory affairs experience, with proven and recent expertise in drug-device combination product submissions and/or medical devices for US, EU, and international markets.

You have a demonstrated ability to develop global regulatory strategies and assemble dossiers for submissions including EU MAA, NBOp, CTA, US IND, NDA, BLA for combination products, 510(k), and PMA; international experience is strongly preferred.

You possess a solid understanding of the drug-device combination and medical device regulatory framework across EU, US, and international markets, including ICH, EU-MDR, MDSAP, ISO 13485, cGMP for combination products, QMS, technical file requirements, eCTD, and MCDG guidelines.

You are a strong team player who thrives in a highly multidisciplinary environment and communicate effectively with colleagues and stakeholders from diverse professional backgrounds.

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! #J-18808-Ljbffr Ready to explore, break barriers, and discover more? We know you\'ve got big plans - so do we.

Our colleagues across the globe love innovating with science and technology to enrich people\'s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That\'s why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Your Role In this pivotal role, you will own and drive the global regulatory strategy for drug-device combination products, shaping the pathway from early development through to approval and lifecycle management.

Your ability to build trusted relationships with regulatory agencies and to translate complex regulatory requirements into clear, actionable strategies will be central to accelerating the development of innovative combination products.

Operating with considerable autonomy, you will influence both internal decision-making and external regulatory outcomes, contributing to a culture of regulatory excellence and risk-based thinking across the R&D organization.

Who You Are You hold a degree in a life science or related discipline (MSc minimum or equivalent); a higher degree such as a PhD in a scientific discipline is preferred.

You have a proven track record of productive collaboration with regulatory authorities through scientific advice meetings, and you are able to act as a credible, influential spokesperson during such interactions. Prior experience with regulatory CMC and connected drug-device combination products for medicinal products is an advantage.

You are fluent in English; proficiency in additional languages is an asset. What we offer We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. 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!