- Terumo Aortic (Sunrise, FL)
- …field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5 years direct experience in ... medical device regulatory affairs if no degree. + Knowledge of US and European regulatory processes, including Class III is strongly preferred. + Preferred… more
- Terumo Medical Corporation (Somerset, NJ)
- …clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, Key Opinion Leaders and physician ... presentations preferred . + Demonstrated experience in the development of regulatory /clinical submissions, preferably as a medical writer for pharmaceutical,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- … regulatory success etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance: Ensure adherence to FDA guidelines for ... 505(b)(2) applications and other regulatory standards.Addressing medical /clinical queries from health authorities. Leadership and Collaboration: Lead… more
- Insmed Incorporated (NJ)
- …experience E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs, drug development, FDA and regulatory ... the future of science, we're in. Are you?About the Role:The Senior Director, Medical Services will provide strategic leadership to Insmed's independent medical … more
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as applicable, for the designated program to support clinical trials where necessary, and… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …**Area of Responsibility:** + Responsible as Management Representative, leading all regulatory inspections related to medical device and combination products ... System (Track Wise) + Author/revise standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guideline and… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …industry **Skills & attributes:** + Understanding of North American pre-and post-marketing regulatory requirements for medical Affairs and Medical ... Discovery and Development Processes; Clinical Development Tools and Processes; Medical Affairs Guidelines; Regulatory Guidelines; Pharmacovigilance Guidelines;… more
- BeOne Medicines (Emeryville, CA)
- …execution, communication and influence with internal stakeholders (eg, clinical development, medical , regulatory , labeling) and external stakeholders (eg FDA, ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
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