- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial… 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
- Globus Medical, Inc. (Audubon, PA)
- …engineering, process improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance, and quality ... Assurance** + Ensure all Globus products and processes meet regulatory and internal quality standards. + Review, improve, and...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… 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
- Merck (North Wales, PA)
- **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the ... and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading edge of… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- CSL Behring (King Of Prussia, PA)
- …experience with 5+ years commercial marketing experience in pharmaceutical, biotech or medical device industry + Preferred experience marketing to HCPs within ... ensuring cost-effective delivery of all programs + Manage the internal legal, regulatory and medical review and approval of new messages and materials to enable… more
- Teleflex (Wyomissing, PA)
- …design control processes, regulatory requirements, and quality standards for medical devices . * Understanding of design verification and validation, risk ... for supporting the ongoing lifecycle management of vascular access devices , ensuring product quality, regulatory compliance, and...2 years of previous experience in related field (eg medical device design and manufacturing, or similar… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... variable factors which may include customer impact, HCUS business priorities and regulatory requirements. Provides to assistance to all connected teams on technical… 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 ... that make a meaningful difference in people's lives. Our medical devices , software and related services are...+ Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.preferred and +… more