- AbbVie (North Chicago, IL)
- …objectives, both strategic and applicable regulatory requirements. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the ... management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA)...quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfolio. The role oversees generation and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …preferred. + You have a minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum of 2 years' ... to the best of my knowledge. **Job Description** **Senior Manager, US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** **Lexington, MA or Exton,… more
- Amazon (Bellevue, WA)
- …tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be ... establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling...verbal, presentation, and organizational skills. - . Experience with medical device software requirements. - . Ability… more
- J&J Family of Companies (Raynham, MA)
- … Medical Device Directives) is required. + Demonstrated expertise in medical device regulatory requirements and processes. + Outstanding project ... regulatory affairs or related/equivalent experience in the Medical Device sector. + Experience with US...in worldwide regulatory systems preferred. + Previous medical device submission experience preferred. + Demonstrated… more
- Abbott (Alameda, CA)
- …of commercial regulatory requirements associated with Advertising and Promotion of medical devices . Utilize technical regulatory skills to propose ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review… more
- Actalent (Schaumburg, IL)
- SR. Engineering Regulatory Specialist ( Medical Device ) We are seeking a hands on regulatory expert that will be responsible for insuring that products ... comply with current and evolving global requirements and regulations. This person will also be responsible for developing test method, conducting product testing and directing external test labs Key regulations include but are not limited to: IEC-60601,… more
- Astellas Pharma (Northbrook, IL)
- …handling regulatory counseling matters for a company in the pharmaceutical or medical device industry. + Deep understanding of the legal issues affecting the ... will be responsible for the following, working closely with the Legal Regulatory Lead for Medical Specialties and Gene Therapy and the Legal Regulatory Lead… more
- Takeda Pharmaceuticals (Exton, PA)
- …+ You will have a minimum of 5 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience ... of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs, Medical , Legal, Commercial, and Compliance, execute and… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience ... landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards,...with stakeholders in HA and in industry for US regulatory activities for devices and combination products… more
- LSI Solutions (Victor, NY)
- …Regulatory Associates provide regulatory feedback and guidance based on medical device regulations and standards to the company throughout the development ... assigned to European regulatory projects will be involved with medical device classification, preparation of technical documentation, conformity assessments,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ MS preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... medical devices (Software as a Medical Device...years of experience with Artificial Intelligence / Machine Learning-enabled medical devices + Expert in Regulatory… more
- Abbott (Pleasanton, CA)
- …+ Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . + Experience of working within ... + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements...years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . +...with either 510(k) applications, PMA supplements, NDA, BLA, US device regulations, US biologics regulations, US drug regulations or… more
- Cordis (Irvine, CA)
- …+ **Develop IFUs:** Write, edit, and maintain clear and compliant IFUs and other regulatory documents for medical devices . + **Package Label:** Develop ... 5 years of experience in technical writing, preferably in regulatory affairs or the medical device...IFUs. Familiarity with clinical data, digital design, and pharma/combo medical devices . + **Skills:** + Exceptional writing,… more
- Teleflex (Maple Grove, MN)
- …documentation materials. * Keep abreast of relevant domestic, European, and other international regulatory requirements for medical devices . * Adhere to and ... Regulatory Affairs Specialist **Date:** Jan 10, 2025 **Location:**...projects. * Assist in producing new or revised global medical device submissions in the format consistent… more
- Abbott (Plymouth, MN)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more… more
- Colgate-Palmolive (Piscataway, NJ)
- …of US and Canada medical device regulations and experience supporting regulatory activities for medical devices . * Experience using SAP and other ... and compliance activities for various product categories, including cosmetics, drugs, and medical devices , ensuring adherence to applicable US FDA and Health… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …equivalent. Science background is preferred. + Masters Preferred. + 6+ years in regulatory affairs or equivalent, medical device /IVD industry, including 4+ ... The Sr. Regulatory Affairs Manager will work with a high...and/or multiple employees. Knowledge and Skills + IVD and/or medical device experience required. + 510(k) and… more
- Hologic (Marlborough, MA)
- …to build high-performing, cross-functional teams. + Exceptional business acumen and expertise in regulatory compliance for medical devices and diagnostics. + ... VP, Regulatory Affairs Marlborough, MA, United States **Vice President of Regulatory Affairs** Are you a visionary leader with a passion for women's health? We… more
- Caldera Medical (Westlake Village, CA)
- …Life for Women! As a regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... in International Regulatory Affairs preferably in the Medical Device industry. * Experience with Class... Device industry. * Experience with Class II medical devices , including implants. * Experience of… more
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