QARA Director (H/F)
Withings, France
Job Description
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:
Withings is seeking a proven leader to join a growing Regulatory team as QARA Director to oversee the global regulatory process for all products. This leader will serve as the main point-of-contact for US and international health authorities and will be the key executive to help the growth and success of the company. You will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for US FDA, EMEA, and other key market Health Authorities. This position is strategic, providing the vision and direction for the regulatory team.
Responsibilities:
- Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals in the US market.
- Expert knowledge of clinical development within US and Global regulatory strategy.
- Assist in clinical studies required for regulatory approvals, including clinical study design, data analysis, and data reduction
- Lead and coordinate activities with the company and management's goals and objectives.
- Represent as main point-of-contact before all regulatory authorities.
- Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
- Assist the team, provide training and interpretations of FDA and other regulatory issues and assist as a liaison between the organization and appropriate regulatory authorities.
- Support the group and oversee all regulatory filings; lead the regulatory activities for all products, including pre-market and post-market requirements.
Requirements
Experience:
- Advanced engineering/scientific degree highly preferred with at least 7 years in the healthcare/pharmaceutical industry, including 5 years of direct management experience leading regulatory responsibilities in a similar organization.
- Strong Global regulatory affairs experience with in-depth knowledge of clinical development and regulatory strategy, as well as preparation and successful execution of health authority interactions.Proven ability to lead multidisciplinary teams towards common goals through development/approval challenges by managing and building consensus among multiple stakeholders.
- Successful track record of working in a complex organization while building strong partnerships with other teams including Ramp;D, Manufacturing and Senior Management Team.
- Must have a solid understanding of FDA regulations for OTC hardware devices and applications. Strong knowledge of CE, TGA amp; MDSAP regulations is a plus.
- Strong and demonstrated leadership skills, problem solving ability along with associated analytical and communication skills.
- Proven experience in leading and managing regulatory affairs and QA functions through teamwork, collaboration and open communications.
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)