- ZOLL Medical Corporation (Pittsburgh, PA)
- …years of experience as a lead inspector or supervisor in an FDA regulated medical device manufacturing environment required. + Must have a strong understanding ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Globus Medical, Inc. (Audubon, PA)
- …Summary:** The Project Engineer will offer technical support for the advancement of medical device and biologic products. This role entails conducting research ... At Globus Medical , we move with a sense of urgency...experimental records, drafts detailed technical reports, and ensures strict compliance with applicable quality and regulatory standards + Possesses… more
- Teleflex (Wyomissing, PA)
- …personnel to support 510(k)s, Canada License applications, European Union (EU) Medical Device Regulations (MDR) submissions, and other regulatory deliverables, ... regulatory activities to meet submission, departmental, and quality system compliance requirements. The Senior RA Associate will partner with... medical technology. * Minimum 2 years of medical device regulatory experience or equivalent. *… more
- West Pharmaceutical Services (Exton, PA)
- …regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety ... addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government...5 years of relevant experience + 2+ years of medical device regulatory experience preferred + Experience… more
- West Pharmaceutical Services (Exton, PA)
- …factors, combination products, delivery system and design controls. + Experience in medical device regulatory affairs and/or design control process, direct ... Requirements** + Ability to comprehend principles of math, science, engineering, and medical device use. + Ability to handle technical reports, drawings,… more
- Merck (West Point, PA)
- …**Required Skills and Experience:** + Subject matter expertise in packaging and/or medical device and combination product components as well as development ... Performance Indicators (KPI), Leading International Teams, Management Process, Manufacturing Scale-Up, Medical Device Regulations, Medical Devices, Packaging… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... enterprise quotes. + Understand the specialized requirements for quoting regulated medical software, hardware, and consulting; ensuring accurate compliance ,… more
- Actalent (Cranberry, PA)
- … devices. This role demands precision, consistency, and a solid understanding of medical device standards. You will work closely with Quality Engineers and ... execution. Responsibilities + Perform dimensional and visual inspections on critical medical device components or assemblies using various measurement tools… more
- CSL Behring (King Of Prussia, PA)
- …cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for ... ICSRs. **Key Responsibilities** Oversight of Case Management Processes activities Oversight of Medical Evaluator role which completes medical review of the… more
- Globus Medical, Inc. (Audubon, PA)
- …**the following:** + 5 years' minimum experience in product development in the medical device field, joint reconstruction experience is strongly preferred + ... At Globus Medical , we move with a sense of urgency...in industry for this group. + Oversee all Quality Compliance activities for products within department including complaint, CAPA,… more