To be considered for this position you must have at least 7 or more years of regulatory affairs experience in the area of "In Vitro Diagnostics" (IVD) along with hands-on preparation of 510K submissions for IVD products. Strongly prefer someone form the medical device industry (not pharmaceutical mfg). Any experience dealing with face-2-face meetings with regulators (like Pre-Submission meetings) will be considered a valuable asset. Provide regulatory strategies for products, including regulatory consultations, product characterization and safety assessments. Write & review regulatory documents, with a "critical eye" for suitability for submissions to FDA and other regulatory agencies as needed. Will be handling pre and regular submissions to the FDA. Assist in defining regulatory submission strategies to assure timely and successful product clearances. Beyond the U.S., interactions could be with Canadian, European, and other international regulatory authorities. A Bachelor's Degree in a scientific or engineering discipline is required. Active participation in regulatory industry associations is a plus. Up to 30% travel may be required. Company will provide relocation assistance. There is also the possibility that this position can be done on a remote basis for someone with strong IVD experience.
Please answer each question (you must be able to answer YES to all 3 questions to be considered & contacted):
1. Do you have IVD experience?
2. Do you have hands-on experience with 510K submission?
3. Do you have face-2-face experience dealing with the FDA?