- Danaher Corporation (Sunnyvale, CA)
- …Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... Certification + ISO 9001:2015 process and assessment certification activities + Regulatory Intelligence program + Technical Writing Cepheid, a Danaher operating… more
- Philips (Plymouth, MN)
- …of healthcare solutions. **Your role** Join Philips Image Guided Therapy (IGT), a medical device manufacturer offering healthcare solutions in the field of ... **Intern - Regulatory Affairs- Minneapolis, MN - Summer 2026** We...and/or a science related field. + General knowledge of medical device regulations (21CFR), FDA law, MDD,… more
- Medtronic (Minneapolis, MN)
- …Responsible for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure ... maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards...Control Charts, & ANOVA; CAPA; and Combination [pharmaceutical and medical device ] Products, (FDA 21 CFR Part… more
- Actalent (Earth City, MO)
- …+ Collaborate with Regulatory Affairs to assess and interpret changes in medical device labeling regulations (FDA, MDR, ISO, and other global standards). + ... + 3+ years of relevant Regulatory Affairs/QA experience, preferably in the medical device industry with knowledge of medical device product labeling… more
- GE HealthCare (Chicago, IL)
- …Qualifications** + Master's Degree and a minimum of 7 years' experience in the medical device or pharmaceutical industry; or Bachelor's Degree and a minimum of ... **Roles and Responsibilities** + Executes against the Quality & Regulatory Business Development Process. This includes scheduling, preparation, execution,...9 years' experience in the medical device or pharmaceutical industry; or will… more
- Danaher Corporation (Richmond, IL)
- …requirements at the Richmond SU Service and Repair shop including proper processing of the medical devices , and training to the QMS procedures. + Lead as the ... field required + 7+ years' work experience with increasing responsibility in medical device /IVD Quality Assurance showing extensive knowledge of medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …years of overall biopharmaceutical/ device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can ... in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory … more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... journal of conferences. *Interfaces with key stakeholders on tasks (eg, Regulatory , R&D, Quality, Marketing, Medical Affairs). *Creates/updates technical… more
- Abbott (Santa Clara, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... / IDE and international submissions + Experience with combination product and/or Class III medical devices + Experience with IDE trial strategy and post market… more
- Medtronic (Los Angeles, CA)
- …industries, with support experience in regulatory body inquiries. + Experience in regulatory compliance guidelines for medical devices (eg ISO, MDD/MDR, ... Understand the various regulations we operate under in the medical device industry and ensure that the...and ensure that the statistical methods applied align with regulatory bodies' expectations. **Must Have (Minimum Requirements)** : _To… more