- Abbott (Alameda, CA)
- …a robust, scalable digital QMS tailored for Software as a Medical Device (SaMD) in a regulated environment. + Regulatory Strategy: Develop and execute ... Quality Assurance and Compliance system optimized for Software as Medical Device . In addition, this individual will...MDR/IVDR. + Successful track record of preparing and submitting regulatory dossiers for medical devices ,… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Merck (Boston, MA)
- …cross-functional impact, including drug device /combination products and software as medical device platforms. Reviews and resolves issues that span diverse ... Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices , Mentoring Staff, Ophthalmology, Pathophysiology, People… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... Care Combination Products, who in turn reports to the Head of GRA Device . The candidate will...to internal regulatory processes and procedures for medical devices and combination products. + Engage… more
- Aerotek (Irvine, CA)
- **Cleanroom Operator** + This position is responsible for the production of high-quality medical devices within a manufacturing cell. + Working under close ... test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. + The role requires spending 95% of… more
- Sanofi Group (Framingham, MA)
- …with a minimum of 15 years relevant experience in the pharmaceutical, biotech, medical device , or related industries. + Extensive knowledge of Quality Systems ... **Job Title:** Compliance Head - US FDA **Location** : Framingham, MA, Morristown,...secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity,… more
- CIBC (Chicago, IL)
- …please visit CIBC.com (https://www.cibc.com/en/about-cibc.html) **What you'll be doing** The Head of US End User Technology Infrastructure Engineering will lead ... employees, enabling productivity and collaboration while maintaining compliance with regulatory requirements. You'll develop and execute the end-user technology… more
- Truist (Dallas, TX)
- …(United States of America) **Please review the following job description:** The Head of Observability and Monitoring will lead the strategy, architecture, and ... skills to drive best-in-class monitoring solutions that align with regulatory and business requirements. **ESSENTIAL DUTIES AND RESPONSIBILITIES** **Technical… more
- Amazon (Seattle, WA)
- …oriented Product Compliance leader to lead the compliance engineering strategy and global regulatory vision for AWS's hardware products. This role will manage a team ... requirements globally - Evaluating and mitigating product design and global regulatory risks related to safety, EMC, energy efficiency restricted substances, and… more
- Ascendis Pharma (Palo Alto, CA)
- …Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team. This role involves ... regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory experience including IND/CTA,… more
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