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

TN Switzerland; Eysins; Vor Ort; CHF 100’000 - 150’000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Manager for Regulatory Affairs in Digital Health and Devices. This role involves developing and implementing regulatory strategies for innovative drug-device combinations and digital health solutions. You will collaborate with multidisciplinary teams and engage with regulatory authorities to ensure compliance and accelerate product development. The ideal candidate will have extensive experience in regulatory affairs, a strong educational background in life sciences, and the ability to communicate effectively across diverse teams. Join this forward-thinking company to make a significant impact in the healthcare sector.

Qualifikationen

• 8+ years in regulatory affairs with drug-device combination products or digital healthcare.
• Experience in building global regulatory strategies for submissions and approvals.

Aufgaben

• Develop global regulatory strategies for drug-device combination products.
• Execute regulatory strategies in collaboration with technical and commercial teams.

Kenntnisse

Regulatory Affairs

Drug-Device Combination Products

Digital Health Solutions (SaMD)

Clinical Development Process

Effective Communication

Stakeholder Engagement

Ausbildung

Master's Degree in Life Science

PhD in Scientific Discipline

Jobbeschreibung

Social network you want to login/join with:

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

Client:

Location:

Job Category:

-

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.