Global Regulatory Digital health and Device Lead (m/f) (could be based in CH or DE)

Posté 15 nov. 2021

Aubonne, Vaud - Switzerland

Demander un identifiant 234033

Détails

 

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

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.

 


Your Role: Responsible for developing and leading Global regulatory strategies for submissions and approvals of clinical trials and original marketing authorization applications for devices or digital health tools within EMD Serono digital health and device portfolios. Implement our wide Digital Health and 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. Provide and lead regulatory strategy for assigned products within the company’s digital health and device portfolios in both Clinical trials or commercialization. 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 10 years of experience in regulatory affairs of medical devices or digital healthcare with at least 3+ in regulatory submissions of digital health tools and Software as Medical Device (SaMD) globally
  • Proven track record of effective collaboration with the regulatory authorities, demonstrated ability to act as a credible, influential, respected spokesperson during interactions
  • Proven record of working in a device or a digital health tool regulatory team that is to be used along with medicinal product or as a part of drug development during a trial.

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

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