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

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

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Job Reference:

fc03f4e4d2a6

Job Views:

3

Posted:

02.04.2025

Expiry Date:

17.05.2025

Job Description:

We are looking for an experienced person to take the position of Senior Manager, Regulatory Affairs, Digital Health and Devices (all genders). Possible work locations: Eysins (Switzerland), Darmstadt (Germany), Boston (US), or London (UK).

The Senior Manager will be responsible for the regulatory strategy of our combination products and medical devices used with Merck’s medicinal products. Key responsibilities include:

1. Developing 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.
2. Implementing drug-device combination products in clinical trial programs aimed at medicinal products.
3. Executing the regulatory strategy for Drug/Device combinations in conjunction with technical, development, commercial, IP, and business development teams to support projects and work streams according to agreed deliverables, timelines, and budget.
4. Identifying and executing opportunities to build trust and partnerships with internal and external stakeholders (such as health authorities) leading to early engagement to accelerate development.
5. Working effectively in a broader matrixed organization to deliver an aligned and successful regulatory strategy.
6. Ensuring compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities.

Who you are:

1. Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g., PhD in a scientific discipline).
2. 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).
3. Proven expertise in building global regulatory strategy including submissions-dossier for EU (MAA/CE-marking) and US (IND, NDA, 510K, PMA) (mandatory).
4. Proven track record of effective collaboration with regulatory authorities, with the ability to act as a credible, influential, respected spokesperson during interactions.
5. Prior experience working with connected drug/device combination products for medicinal products is desirable.
6. Good understanding of the clinical development process, trial design aspects, and relevant clinical regulatory frameworks such as ICH, GCP, MDR, and MCDG.
7. Strong team player; able to work within a highly multidisciplinary environment.
8. Effective communication with team members and stakeholders with diverse backgrounds.
9. Fluency in English is mandatory.