Senior Manager, Regulatory, Digital Health and Device (all genders)

Work Your Magic with us! 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. 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. Senior Manager, Regulatory Affairs, Digital Health and Devices (all genders) Possible work locations: Eysins (Switzerland), Darmstadt (Germany), Boston (US) or London (UK). Your Role: We are looking for an experienced person to take the position of Senior Manager, Regulatory Affairs, Digital Health and Devices (all genders) who will be responsible for the regulatory strategy of our combination products and medical devices used with Merck’s medicinal products. Develop global regulatory strategies for submissions and approvals of drug-device combination products (including co-packaged medical devices) or digital health solutions (SaMD) for marketing authorization applications and clinical trials within Merck’s digital health and device portfolio. Implement drug-device combination products in clinical trial programs aimed at medicinal products. Implement our drug/device combinations products regulatory strategy, in conjunction with technical, development, commercial, IP and business development teams by supporting projects and work streams according to agreed deliverables, timelines and budget. Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant internal and external stakeholders (such as health authorities) leading to early engagement to accelerate development. Work effectively in the broader matrixed organization to deliver an aligned and successful regulatory strategy. Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities. Who you are: Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline). Over 8 years of experience in regulatory affairs of medical devices OR drug-device combination products OR digital healthcare (SaMD) with at least 3 years in regulatory strategy of drug-device combination products globally (mandatory). Proven expertise in building global regulatory strategy including submissions-dossier for EU (MAA/CE-marking) and US (IND, NDA, 510K, PMA) (mandatory). Proven track record of effective collaboration with the regulatory authorities, demonstrated ability to act as a credible, influential, respected spokesperson during interactions. Prior experience working with connected drug/device combination products for medicinal products is desirable. Good understanding of the clinical development process, trial design aspects, and relevant clinical regulatory frameworks such as ICH, GCP, MDR and MCDG. Strong team player; able to work within a highly multidisciplinary environment. Effective communication with team members and stakeholders with diverse backgrounds. Fluency in English is mandatory. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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! Apply now and become a part of our diverse team! #J-18808-Ljbffr