VP of Regulatory Affairsjuillet 3, 2019
Allurion Technologies is a rapidly growing, global, venture-backed healthcare company headquartered in Natick, Massachusetts with offices in Paris and Dubai. The Company was founded in 2009 by two Harvard Medical School students dedicated to helping consumers lose weight. The Company’s flagship program features the Elipse Balloon, a procedureless device for the treatment of overweight and obese consumers, an Allurion Bluetooth® body composition scale, and an Allurion smartphone app that tracks the user’s progress throughout their weight loss journey. The program leads to 25 to 30 lbs of weight loss in 4 months. The Elipse Balloon is placed in a 15-minute office visit and does not require surgery, endoscopy or anesthesia for placement or removal. The Company launched commercial operations in 2016, and 15,000 consumers have already experienced the Elipse Program across 20 countries in Europe, the Middle East, and Latin America. In 2018, the company commenced a pivotal study for FDA approval which is now complete. Allurion has been recognized as one of Fierce Medical Device’s Fierce 15, one of Boston’s 50onFire, and a top Emerging Technology by SAGES.
The Vice President of Regulatory Affairs is responsible for leading all submissions and communications with regulatory authorities and managing international product registrations. The Vice President of Regulatory Affairs will report directly to the CEO and work closely with other company leaders to execute the company’s global regulatory strategy.
- Lead the preparation and review submissions to the FDA
- Lead the preparation and maintenance of the product’s Technical File and registration status globally
- Lead cross-functional team members to complete the MDD to MDR transition for CE-marked products
- Manage international product registration and licensing requirements, including the day-to-day responsibilities of regulatory submissions
- Provide guidance and oversight for any recalls, complaints, and regulatory reporting
- Evaluate, propose and implement new processes and technologies to optimize efficiencies in the Regulatory Department
- As required, manage contractors/service providers who support Regulatory submission goals
- Effectively communicate with leadership on the status, objectives, risks, and mitigation plans associated with the various internal projects, as well as ensure regulatory teams are aware of current integrated program timelines
- Interacts with regulatory authorities for Allurion regulatory inquiries
- Remains current with regulatory intelligence and ensures Allurion submissions are aligned with current standards/expectations.
- Demonstrate expert knowledge of submission or technology-related global Health authority guidelines/regulations.
- Represent Allurion on industry associations and both influence and provide input to intelligence/policy initiatives in alignment with internal and external stakeholders, ensuring a focus on Allurion’s best interests.
- 15+ years of regulatory affairs experience, preferably with major marketing application experience, preferably in medical devices
- Proven ability to successfully plan for and manage new regulatory submissions while overseeing the routine daily maintenance of existing regulatory applications
- Successfully manage regulatory submissions projects such that they integrate effectively with the overall objectives of the Allurion programs they support
- Ability to motivate and influence colleagues through collaborative approach
- Excellent communication, analytical, and organizational skills
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
- Working experience with regulatory processes; particularly those employed in EU, GCC, APAC, LATAM, and the USA.
- Bachelors Degree or higher (life sciences preferable)
- Salary will be commensurate with prior experience
- Comprehensive medical, dental, vision, life and disability insurance
- Tuition reimbursement
- Newborn baby care allowance
- Generous holiday schedule
- 3 weeks paid time off
- Stock options
- Company-matched 401K savings plan
Must be authorized to work in the US.
Qualified applicants should submit a resume to:
Must be authorized to work in the US
Allurion Technologies is an Equal Opportunity Employer