- Beckman Coulter Diagnostics (Miami, FL)
- …the preparation and submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business ... we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always… more
- Cytiva (Miami, FL)
- …to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits ... in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good… more
- Kelly Services (Gillette, WY)
- …and launching a state-of-the-art research laboratory dedicated to shaping the future of healthcare . As a **Senior FDA Regulatory Affairs Specialist** , ... regulatory teams to meet safety and efficacy standards. ** Regulatory and Compliance Expertise:** + Lead FDA ...experience in regulatory affairs, product development, or FDA submission leadership in a healthcare or… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …development through commercialization, including advising on a broad range of healthcare regulatory matters, including labeling negotiations, advertising and ... industry, including product development, commercialization, and the legal and regulatory environment (including healthcare fraud and abuse, anti-kickback,… more
- AdventHealth (Orlando, FL)
- …drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA . The Research Regulatory Specialist III supports AHRI investigators ... applications. Provides data and document collection and compilation for regulatory filing with the FDA and other...manner. + **Minimum qualifications** : + Bachelor's degree in healthcare related field or biological sciences; and at least… more
- Rush University Medical Center (Chicago, IL)
- …engineering program, including vendor oversight. Strong knowledge of Joint Commission, CMS, FDA , and other healthcare regulatory standards. Experience with ... management of biomedical equipment. Ensure compliance with The Joint Commission, CMS, FDA , and other regulatory requirements. Lead and manage relationships with… more
- BeOne Medicines (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- AdventHealth (Orlando, FL)
- …new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA ; and coordination of the regulatory activities for AHRI led ... + Provides data and document collection and compilation for regulatory filing with the FDA and other...training. + **Minimum qualifications** : o Bachelor's degree in healthcare related field or biological sciences and at least… more
- Houston Methodist (Houston, TX)
- …study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- J&J Family of Companies (Raritan, NJ)
- … regulatory strategies, PMR fulfillments, and other US-related issues. * Leading the regulatory response team for FDA and Health Canada questions. * Managing ... At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,… more
