- ZOLL Medical Corporation (Pittsburgh, PA)
- … devices in domestic and international markets. + Post-market surveillance and medical device reporting in domestic and international markets + Responsible ... 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
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Organon & Co. (Plymouth Meeting, PA)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...CMC with demonstrated understanding of related pharmaceutical, biological or device operations (eg, manufacturing, process development, analytical, and quality… more
- United Therapeutics (Harrisburg, PA)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
- PCI Pharma Services (Philadelphia, PA)
- …in quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive) + Strong knowledge of cGMP and other applicable ... requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ... discipline. required + Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.preferred and + Experienced in… more
- Omnicell (Pittsburgh, PA)
- …field, with prior experience in a leadership role + Strong understanding of medical device design, regulatory processes, system integration, and standards ... creation and maintenance of documentation, and ensuring compliance with relevant medical device regulations + Other duties include troubleshooting, mentoring,… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …development of complex electronic and software systems required. + Experience with medical device development including regulatory requirements required. ... 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
- Olympus Corporation of the Americas (Center Valley, PA)
- …to meet regulatory / procedural deadlines. + Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and ... (https://www.olympusamerica.com/careers) . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution… more
- Merck (West Point, PA)
- …Reporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform Packaging and ... to ensure compliance with relevant regulations and standards. Ensure thorough engineering, medical device and packaging science is applied to deliverables for… more