Be in charge of the Regulatory Affairs and Quality Assurance of the company. The ideal candidate will be an integral part of establishing MDR for the company. They will also be instrumental in ensuring the quality of out going products and providing support and making recommendations to the CEO and senior staff for strategic planning purposes.
Essential Job Functions
*Responsible for the promotion of regulatory and customer requirements. *Primary interface with FDA and ISO auditor. *Interface with engineering in the risk management process. *Organizes data collection and information analysis; create reports. *Responsible for overseeing/maintenance of the internal audit program. *Maintains Quality Manual, procedures and logs.
Requirements
*Bachelor’s Degree: Engineering/Business/the Sciences *Prior experience in ISO certified companies; familiarity with ISO: 13485:2003, 21 CFR Part 820, 93/42/Medical Device Regulations. *Experience with FDA Submittals. *Knowledge of Risk Management. *Knowledge of MDSAP & MDR a plus.