RA Manager (H/F)
Withings, France
Job Description
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.
Withings is seeking a proven leader to join a growing Regulatory team as Regulatory Manager 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.
Missions
- 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
- Advanced engineering/scientific degree highly preferred with at least 5 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 CE MDR and FDA regulations for Rx hardware devices and applications and CE MDR. OTC (over the counter) experience and strong knowledge of 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 through teamwork, collaboration, and open communications.
Benefits
Joining the Withings adventure means :
- Joining one of the world's pioneers and leaders in connected health, winner of several awards at the Consumer Electronic Show,
- Contributing to innovative and ambitious projects for the health of tomorrow in an agile and constantly evolving environment,
- Join an international company, member of the FrenchTech 120, with teams based in Issy-les-Moulineaux, Boston, Hong-Kong and Shenzhen,
- Participate in the continuous improvement of our products and services by beta-testing them before their release, especially during our numerous sports sessions with colleagues,
- Benefit from numerous advantages: Stock Options, smartphone and computer of your choice, discounts for cultural and sports activities, company restaurant, and much more,
- Participate in the Withings Med Academy by attending lectures by healthcare professionals to strengthen your knowledge in the medical field,
- Collaborate with passionate colleagues and celebrate each of our successes together!
All applications received are considered regardless of the applicant’s ethnicity, beliefs, religion, gender, sexual orientation or health. Withings aspires to offer and guarantee equal opportunities to