Director of Regulatory Affairsjanvier 31, 2019
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 placed in a 15-minute office visit and does not require surgery, endoscopy or anesthesia for placement or removal. 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.
The Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategies for the U.S., EU, and global regulatory activities. This position reports directly to the Chief Executive Officer. This person manages Regulatory Affairs staff in addition to oversight responsibility for Regulatory consultants. This position coordinates departmental planning, manages multiple projects and project teams and provides the regulatory strategies to ensure appropriate implementation of key business initiatives. The position requires acting as the liaison with the FDA, the Notified Body and other global regulatory agencies with responsibility for regulatory submissions.
Principle Duties and Responsibilities
- Develop and implement global regulatory strategy and manage those systems and programs in order to meet corporate goals and objectives
- Coordinate department planning to ensure that the Regulatory Department functions optimally and within the budget
- Prepare and review PMA and IDE related submissions to the FDA. Lead technical staff to prepare and maintain product Technical File. Prepare design dossier submission when needed. Lead cross functional team members to complete MDD-MDR transition for CE marked product(s).
- Be and develop subject matter experts on current FDA Regulatory Guidance and standards as well as Europe, Africa and GCC-APAC
- Manage international product registration and licensing requirements
- Review and interpret current regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
- Ensure that the Regulatory Department interfaces with key functional groups (R&D, Manufacturing, Sales, Marketing, Quality Assurance and Clinical) to drive company-wide, cross-departmental initiatives
- Grow Regulatory team as needed and coach them in all aspects of their responsibilities
- Participate in the short and long range planning of new product opportunities
- Provide management-level representation during internal and external GCP audits
- Oversee the Regulatory Department SOP review and development, employee training and associated requirements
- Regularly make presentations to senior staff members
- Procure and oversee outside vendors and consultants, as required
- Bachelor degree in engineering, biological sciences or related medical/scientific field
- Minimum 15 years regulatory experience in the medical device industry, with proven track record of successful submissions to FDA of IDEs, 510(k)s and PMAs
- Certificate in Regulatory Affairs preferred
- Experience preparing PMAs preferred
- Experience with preparing and maintaining Technical File. Familiar with EU MDD and experience working with Notified Bodies.
- International regulatory experience desirable, including Africa and GCC-APAC. Proven ability to work in a matrix environment
- Excellent written, oral and interpersonal communication skills
- Proficient knowledge of medical terminology
- Expertise with FDA and EU regulations, in particular EU, Africa and GCC-APAC and international regulatory compliance guidelines and proven track record in similar role
- High attention to detail and accuracy with strong prioritization and organizational skills
If you are a qualified applicant, please submit your resume and cover letter to: HR@allurion.com
Please note that Allurion is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.