- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Mount Sinai Health System (New York, NY)
- …science or legal/ regulatory studies + 3+ years of direct experience in Regulatory Affairs, Clinical Affairs or Quality Assurance within the Medical Device ... **Job Description** A Regulatory Compliance Coordinator position is currently available within...and obtains approval from the Food and Drug Administration ( FDA ) for investigator-initiated clinical trials. Acts as primary contact… more
- Abbott (Plymouth, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... to support Abbott customers. + May interface directly with FDA and other regulatory agencies if so...experience in a regulated industry (eg, medical products, nutritionals). Regulatory area is preferred but may consider quality… more
- ITG Brands (NC)
- …tobacco and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and ... regulatory industry (tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state- regulatory compliance, regulatory… more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more
- Abbott (Santa Clara, CA)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... requests for product release. + May interface directly with FDA and other regulatory agencies if so...initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …of each protocol are compliant and fully covered. + Perform internal audit and quality assurance checks on regulatory documents. + Prepare, track and maintain ... all correspondence and regulatory documentation required by the IRB, FDA , IND Sponsors, and other institutional and federal oversight committees, including… more
- Philips (New Kensington, PA)
- …right fit if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and execute the...EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA… more
- Takeda Pharmaceuticals (Boston, MA)
- …for Late-Stage assets. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part...a professional and timely manner. + Accountable for US FDA submissions and approvals of project(s) of responsibility. May… more
- Takeda Pharmaceuticals (Boston, MA)
- … and/or related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, ... on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of...lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for… more