- CSL Behring (PA)
- …surgery, organ transplantation and burn treatment. Could you be our next Senior Manager , Analyst, Regulatory Science, Policy, and Intelligence? The job is in ... assigned platforms, departments, or topics. Help identify opportunities for non- product -specific collaboration with global regulatory authorities. Collaborate… more
- Jabil (West Chester, PA)
- …globe. Are you experienced in Regulatory Compliance? Jabil is seeking a qualified Regulatory Compliance Manager to work in West Chester, PA. As the ... Regulatory Compliance Manager , you will manage all Regulatory Compliance...product manufacturing process and compliance with all applicable regulatory requirements. This person will also be responsible for… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …and initiatives that significantly impact the business. + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Globus Medical, Inc. (Audubon, PA)
- …years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + Solid understanding of ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...pre-market submission types, and requirements + Able to evaluate regulatory impact of proposed product and process… more
- Globus Medical, Inc. (Audubon, PA)
- …knowledge of IDE and PMA submissions a plus + Experience assessing regulatory impact of product /process changes + Experience reviewing labeling, promotional ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Wolters Kluwer (Philadelphia, PA)
- **Lead Technology Product Manager ** - Commercial Drug Information This role follows a hybrid model, offering the flexibility to work remotely while staying ... **SUMMARY** As part of the **Wolters Kluwer Health team** , the **Lead Technology Product Manager for Medi-Span** plays a critical role in advancing our… more
- PCI Pharma Services (Philadelphia, PA)
- …in a regulated environment + Demonstrated expertise in quality management systems and regulatory requirements ( FDA , ISO 13485, Medical Device Directive) + Strong ... to pioneer and shape the future of PCI. The **Quality Systems Manager ** is responsible for overseeing and maintaining the Electronic Quality Management System… more
- Philips (New Kensington, PA)
- …removal tasks, ensuring compliance and swift resolution of issues to uphold product safety and regulatory compliance, fostering transparency and cooperation in ... The Senior Manager -Corrections & Removals (C&R) will manage a team...efficiency/effectiveness of C&R processes and maintains strict compliance with regulatory requirements governing product corrections and removals.… more
- Cardinal Health (Harrisburg, PA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... proposals for recommended action. + Support research to maintain a pulse on product , supplier, regulatory , and market dynamics; understand how industry trends… more
- TreeHouse Foods, Inc. (Lancaster, PA)
- …quality systems and initiatives. . Serve as the plant's liaison for regulatory authorities, including USDA, FDA , and third-party auditors. **_Important ... Type:** Quality **Job Posting Title:** Food Safety and Quality Manager **About Us** **:** TreeHouse Foods (NYSE: THS) is...PA site, a manufacturer of pretzels. This role upholds product quality, food safety, and sanitation in compliance with… more