- Regeneron Pharmaceuticals (Troy, NY)
- …(eg, change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial ... candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role involves overseeing… more
- Black Hills Energy (Lincoln, NE)
- …Level II:$77,450 - $116,200 Senior:$90,900 - $136,500 Reporting Relationship: Manager Regulatory Location:Lincoln, Nebraska Relocation Assistance:Relocation ... Regulatory Analyst II or Senior Location: Lincoln, NE,...studies. Present analytical conclusions (orally and in writing) to management , and other partners in an organized, concise and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …information. + Provide dashboard updates concerning current pending and future approvals for Regulatory Affairs management . + As needed assist in the development ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports regulatory… more
- AbbVie (Mettawa, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Change Enablement reports to the Associate Director of Review ... building alignment among internal teams and external partners. The Change Enablement Manager thrives at the intersection...heard and issues are swiftly addressed + Applies leading change management methodologies to assess and improve… more
- Medtronic (Fridley, MN)
- …and overall business strategy. + As required, may possess strong change management communications capabilities and understanding of organizational dynamics ... more connected, compassionate world. **A Day in the Life** The Medtronic Regulatory Affairs team is seeking a dynamic and experienced communications professional to… more
- Mondelez International (East Hanover, NJ)
- …fast, and passionate about making an impact. We are now looking for a Sr. Product Change Manager to lead the execution of projects that will transform how we ... escalate them to global leads and/ or the program manager when needed + Provide project reporting and status...tight timelines. + Strong analytical thinking and familiarity with change management and governance practices. + PMP… more
- Dairy Farmers of America (Mechanicsburg, PA)
- …activities, ensuring employees work in accordance with departmental policies, procedures, and regulatory standards. In conjunction with the quality manager , help ... and QA Specialist employees who verify DFA records are produced and distributed to the highest regulatory and quality standards. Monitor all stages of record review… more
- International (Lisle, IL)
- …the front-line representative for International supporting compliance related issues. The Regulatory Compliance Manager supports a variety of reporting ... compliance with the EPA, CARB, and ECCC. Strong management and Government relations skills will be required as...emission labelbuild error reports + Reviewing and approving product change control requests and notices for regulatory … more
- Medtronic (Los Angeles, CA)
- …compassionate world. **A Day in the Life** In this exciting role as a Quality System Manager - Change Control, you will have responsibility for leading the QMS ... change control process for the Medtronic Diabetes business. This...guidelines. + Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure… more
- Globus Medical, Inc. (Audubon, PA)
- …Affairs personnel, as needed for IDE and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + ... resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for… more