Regulatory Affairs Senior Principal/ManagerSeptember 6, 2018
Allurion Technologies is a rapidly growing medical device company located in Natick, Massachusetts. The Company developed and markets the Elipse™ Device, an innovative device for the treatment of overweight and obese patients. The device is class III in the US and class IIb in the EU. The Elipse Device was recognized as the top emerging technology of 2016 by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Search Elipse Balloon online or visit our website www.allurion.com for further information.
ROLES AND RESPONSIBILITIES
The ideal candidate will have 8+ years’ experience in the medical device regulatory field, or combined experience in Regulatory, Clinical and Technical Writing, be self-motivated and can thrive in a fast-paced entrepreneurial environment. Experience in writing CER is preferred.
Specifically, this individual contributor will be responsible for:
- Work independently with minimal supervision on regulatory related assignments.
- Lead team effort to transition technical documents from meeting MDD to MDR requirements.
- Maintain EU Technical File and other registration documents
- Provide guidance to cross functional team on regulatory requirements for US, EU, Canada and other markets.
- Review and assess engineering change orders for impact to regulatory status of the product.
- Create and assemble technical and compliance documentation required to obtain regulatory approval.
- Maintain records and quality system documentation for regulatory submissions, notifications, and approvals.
- Other regulatory activities as assigned.
- Bachelor’s degree in a scientific field.
- Ability to work in a challenging and fast-paced work environment.
- Excellent technical writing skills.
- 8+ years of Regulatory Affairs experience or combined experience in RA, Clinical and technical writing required.
- Experience in writing CER is a plus.
- Good communication skills
- Knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) required.
- Familiarity with quality system requirements (ISO 13485, Medical Device Directive) desired.
- Salary will be commensurate with prior experience
- Comprehensive medical, dental, and vision insurance
- Tuition reimbursement
- Newborn baby care allowance
- Generous holiday schedule
- 3 weeks paid time off
- Stock options
- Company-matched 401K savings plan
Qualified applicants should submit a resume and expected salary to: HR@allurion.com
Allurion is an equal opportunity employer.
PLEASE NOTE : We are not using agencies to fill this opportunity.