- Jabil (West Chester, PA)
- …experience, preferably QA exempt personnel + Knowledge of the US and international medical device quality system regulations, standards and best practices ... will also be responsible for the absence of significant quality systems issues and regulatory compliance actions...least five (5) years of experience in the QSR/ISO-regulated medical device operation, including 2-3 years specific… more
- West Pharmaceutical Services (Exton, PA)
- …5 years Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and ... With minimal support, the Sr. Specialist ensures timely and high- quality execution of all regulatory deliverables and...legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global… more
- United Therapeutics (Harrisburg, PA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- Organon & Co. (Plymouth Meeting, PA)
- …or device operations (eg, manufacturing, process development, analytical, and quality assurance) is required. + At least five years of relevant experience, ... project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on… 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 ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… 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
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… 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, ... (https://www.olympusamerica.com/careers) . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution… more
- Cook Medical (Vandergrift, PA)
- …Physical Sciences, or related area.Minimum 3 years of experience working in a Medical Device or Life Sciences Quality Management System.Experience in ... - Collaborate with other departments to achieve desired results in audit responses, quality system change tracking, and regulatory compliance analyses. - Attend,… more
- Organon & Co. (Plymouth Meeting, PA)
- …GMP Quality Systems and regulatory requirements. + Experience in medical device Quality Systems is preferred, including familiarity with ISO13485, ... stored, and distributed in accordance with Organon expectations and all applicable regulatory requirements. The External Systems Quality Leader (ESQL) serves a… more