- AbbVie (Irvine, CA)
- …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
- 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
- 3M (Maplewood, MN)
- …or other EHS program + Experience with CDMS database + Experience working in regulatory , medical device , product responsibility or EHSR corporate staff in ... Job Description: Job TitleSenior Regulatory Affairs Associate Collaborate with Innovative 3Mers Around...variety of regulated markets, including construction, automotive, electronics, consumer, medical device , and food contact. + Builds… more
- ICU Medical (Lake Forest, IL)
- …degree from an accredited college or university required// * Minimum 0-2 years of regulatory and medical device experience, or equivalent * Must have ... International product registrations and export certifications as requested by ICU Medical distributors and international regulatory agencies. / / *Essential… 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 (Lexington, MA)
- …+ 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
- Edwards Lifesciences (Irvine, CA)
- …negotiation and drafting, etc.). + Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. + Other duties and ... and interests of the patients we serve. The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...+ Experience reviewing advertising and promotional materials in the medical device or pharmaceutical industry. Aligning our… 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
- 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 (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
- ConvaTec (NJ)
- …+ RAPS Certification preferred + 3-5 years' experience preferred **Competencies:** + Regulatory /Quality experience in medical devices + Experience dealing ... and contribute to the company's continued success in the medical device industry. **Duties and Responsibilities** :...and submission of EU technical documentation + Experience of regulatory requirements for medical devices … 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
- ManpowerGroup (Alameda, CA)
- Our client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. The ideal candidate should be strong in ... Range: $50-$55/hr on W2** **Education:** Bachelor's degree **Experience Background (Any):** APAC regulatory submissions in Medical Devices or Pharmaceutical… 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
- ZOLL Medical Corporation (Chelmsford, MA)
- …Regulatory Affairs or Regulatory Affairs Certification preferred + Experience with medical device regulatory submissions (510(k) or PMA preferred + ... that make a meaningful difference in people's lives. Our medical devices , software and related services are...Experience with medical device submissions preferred + C ommissioned… more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for...orthopedic medical devices ; + Experience in medical … 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 ... govern the design, development, manufacturing, and distribution of our medical devices . ESSENTIAL FUNCTIONS: Regulatory ...Provide regulatory feedback and guidance based on medical device regulations and standards to the… more