About us:
Withings revolutionized connected health by launching the world's first Wi-Fi scale in 2009. Our award-winning ecosystem includes beautifully designed, easy to use connected devices for monitoring blood pressure, weight, activity, sleep, temperature, and more.
Now our devices are used for preventive health and weight-loss programs, telehealth and remote patient monitoring, and clinical studies. They are the key enabling technologies which support our partners’ strategies by accurately and reliably providing the data amp; metrics they need in order for their programs to be successful.
About the role:
We are looking for a Regulatory Affairs Specialist to join us in this mission to help change the way people take care of their Health.
As Regulatory Affairs Specialist, you will be dedicated to the US region. The Regulatory Affairs Specialist is responsible for planning and executing all activities necessary to obtain and maintain regulatory approvals within the US.
This is a high-responsibility role within a highly strategic division, and we are looking for extremely motivated individuals who want to actively participate in the construction of this new business unit.
Responsibilities:
- Define the US regulatory strategy
- Prepare and submit US regulatory submissions (510(k), De Novo applications)
- Be the key contact for all interactions with the Food and Drug Administration
- Support post-market regulatory compliance activities
- Participate in FDA inspections as required
- Manage all the regulatory surveys applicable to US regulations
- Ensure that FDA import requirements are met
- Review change orders and assess regulatory amp; labelling impact of product changes on US regulatory strategy and submission per standard procedures
- Review labeling, training, promotional and advertising material for US regions
Requirements
Experience:
- Enthusiasm for Withings' preventive health mission and the potential of technology to improve our lives
- Desire to work hard and collaborate cross-functionally with diverse global teams
- Master’s degree in Life Sciences
- 4+ years of Regulatory Affairs experience, acquired within a manufacturer of connected medical devices
- Experience and success in US regulatory submission
- Experience directly interacting with the FDA
- Ability to act as primary contact with FDA and other regulatory agencies
- Must be capable of gathering information from different departments of Withings (software, mechanics, clinical)
- Strong knowledge of all US regulation applicable to medical software, electro-mechanical devices
- Regulatory Affairs Certification (RAC)
- Experience with Quality System Requirements (QSR) in the US
Soft Skills:
- Strong organization and time management skills
- Ease to interact with all company department
- Problem solver
- Strong communication skills
This position will be based in our Issy les Moulineaux office. Some travel to meet FDA or other regulatory agencies would be required.
Benefits
You are hesitating? We tell you why you should join us:
- Our teams are young, dynamic and work with passion
- We kept our start-up spirit and we love to celebrate together our success
- Agility and reactivity are our key words
- You will become a beta tester and you will contribute directly to the development and continuous improvement of our products
- We are sport lovers and will welcome you with pleasure in our different teams
- We are located on the line 12 (Porte de Versailles or Corentin Celton) surrounded by restaurants (Italian, Lebanese, Asian, fast food etc) and parks and sports facilities.
- Work with us, it’s more than a simple job, it’s to become a Withinger (with all the good humour and excellence that it requires)