Regulatory Manager
Regulatory Manager
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Job Description
At Withings we are driven by a mission to empower people to take control of their health.
We are passionate about designing products that are not only innovative but also thoughtfully designed and intuitive to use. Our connected scales hybrid watches blood pressure monitors sleep trackers and other devices are trusted by millions of users worldwide for seamless integration into their daily lives.
Our vision is to revolutionize healthcare through prevention early detection and support for chronic diseases. By combining cuttingedge technology with user friendly design we are transforming the way individuals monitor and manage their health.
To maintain the highest standards of innovation and compliance we are seeking a US RA Manager to join our Quality and Regulatory Affairs team.
There is a strong preference for medical device regulatory experience/background.
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.
- Support in clinical studies required for regulatory approvals including clinical study design data analysis and data reduction.
- Represent as main pointofcontact for the FDA managing communications meetings and document submissions (e.g. 510(k) PMA IDE etc..
- Oversee the preparation and submission of regulatory filings ensuring timely and accurate submissions to the FDA and other authorities.
- Provide overall review daytoday management and operational success for all regulatory functions including the successful integration of activities crossfunctionally.
- Assist the team provide training and interpretations of FDA.
- Ensure that all products comply with US regulatory requirements including safety efficacy and labeling standards.
- Monitor changes in regulatory guidelines and communicate impacts to the broader team.
- Manage reporting and addressing adverse events recalls or other compliancerelated matters.
- Conduct and oversee FDA inspections and internal audits in compliance with 21 CFR requirements.
- Update procedures and quality documentation as necessary to ensure alignment with FDA regulations.
- Support the planning and of market entry strategies for new products in the US including regulatory approvals and clearances.
Requirements
- Advanced engineering/scientific degree strongly preferred with at least 5 years in the healthcare industry including a minimum of 2 years in direct management of regulatory affairs in a similar organization.
- Strong FDA regulatory affairs experience with a deep understanding of clinical development regulatory strategy and the preparation and of successful interactions with health authorities. Demonstrated ability to lead multidisciplinary teams navigate development/approval challenges and build consensus among diverse stakeholders.
- Proven success in working within complex organizations fostering strong partnerships with crossfunctional teams such as R&D Manufacturing and Senior Management.
- Indepth knowledge of FDA regulations for both Rx and OTC hardware devices and applications.
- Strong leadership skills with a problemsolving ability advanced analytical and communication skills.
- Proven track record in leading regulatory affairs through teamwork collaboration and transparent communications.
- This position will be located at our Boston MA office with occasional travel required to meet with the FDA other regulatory agencies or the French team.
Benefits
As youre making the world a healthier place for others we strive to make it a healthier place for you:
- Health Care offerings including options with no employee paid premiums
- All employees receive One Medical and Talkspace memberships
- 6 retirement plan match 401k)
- Life insurance & disability options at no cost to you
- Competitive Paid Time Off plans (vacation sick & public holidays)
- Family Leave (Maternity Paternity)
- Wellness and preventative care reimbursements
- Daily lunch stipends
- Employer funded HSAs
- Healthcare & Dependent Care FSA
- Employer funded commuter FSA
- Biketowork benefit
- Own and beta test all of our products
- Flexible hybrid work
Equal Opportunity at Withings
At Withings we know that diversity equity and inclusivity are paramount to fostering innovation. We rely on the unique skill sets life experiences and perspectives of each team member to accomplish our missioncreating technology that people love to make better health part of everyday life.
Accommodations
If there is anything we can do to accommodate you to participate fully in the recruitment or interview process please let us know by reaching at to
Required Experience:
Manager
Employment Type
Full-Time
