Director, Quality Assurance & Regulatory Affairs OmniGuide
This is a key role for the organization as the leader of this important function managing all Quality and Regulatory initiatives and driving the strategy. This position will manage a group of 4-5 Regulatory and Quality professionals. The company plans to extend use of its products into new markets, and a major objective for this position is to work closely with marketing to secure the best possible claims for these new applications. On the quality side, the position?s objective is to maintain high quality and continue making improvements going forward.
Essential Duties & Responsibilities:
Quality System Management Representative.
Responsible for the overall implementation and maintenance for the OmniGuide Quality
Point of contact for ISO and US FDA auditors.
Responsible for updating the Senior Management on the status of the Quality System and all regulatory submissions.
Responsible for developing regulatory strategies and submissions to the US, European and other countries? regulatory bodies for the approval of medical devices.
Support the Operations department in process improvements and validations.
Support the R&D and Engineering Departments with product design and testing validations.
Responsible for all complaint handling and reporting to regulatory agencies.
Provide leadership to the RA and QA departments.
Must have 10+years senior management experience in a medical device manufacturing environment.
A strong understanding of 21CFR820 FDA Quality System Regulations, ISO 13485 and MDD 93/42/EEC.
Must have effective communication skills (oral and written).
Proficient in MS Office and statistical software.
BS in Science or Engineering required, professional certifications preferable.
Cambridge, , United States
||One Kendall Square, Building 100 |
Cambridge, MA 02139