- Actalent (St. Paul, MN)
- …on sustaining engineering. The team is responsible for managing changes to medical devices after commercialization, ensuring that any changes in raw materials do ... standards. Responsibilities + Manage and sustain engineering changes for commercialized medical devices. + Ensure product integrity amidst changes in raw materials.… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist , Regulatory Affairs - Medical Device Requisition ID: 69746 Date: May 13, 2025 Location: Exton, Pennsylvania, US Department: ... planet through our sustainability efforts. **Job Summary** The Sr. Specialist , Regulatory Affairs, Medical is...requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for… more
- Amgen (Cambridge, MA)
- …and transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** ... Quality Management - ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong background in documenting… more
- Hologic (Marlborough, MA)
- Medical Device Reporting Specialist Marlborough, MA, United States We are seeking a detail-oriented and proactive Medical Device Reporting ... considerations for treatment **Experience:** + 2-5 years progressive quality experience in Medical Device or related Industry. + Bachelor's Degree in Medicine,… more
- PCI Pharma Services (Bedford, NH)
- …our global network to pioneer and shape the future of PCI. The **QA Operations Specialist I - Medical Device Floor Support** is responsible for providing ... QA support of Manufacturing and Visual Inspection activities for clinical and commercial medical device products in a GMP facility. The work scope includes… more
- Merck (Rahway, NJ)
- …medical devices and combination products globally. * Experience in design controls, device risk management, medical device , complex combination product ... are the cornerstone of decisions and expectations * Lead technical investigations of medical device and combination product needs for commercial products *… more
- Fujifilm (Salt Lake City, UT)
- …activities. + Keep abreast of new legislation and enforcement matters relevant to the medical device industry as well as industry and compliance best practices. ... Degree. + 2 to 3 years of corporate compliance experience in the medical device and/or pharmaceutical industry and working knowledge of healthcare related… more
- Abbott (Plymouth, MN)
- …of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly ... scientific affairs function. **Preferred** **Qualifications** + 4+ years of related regulatory submission experience from medical device , pharmaceutical,… more
- Abbott (Plymouth, MN)
- …changes for compliance with applicable regulations. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Supports all ... ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Kelly Services (Dublin, CA)
- **Sr. Process Engineer ( Medical Device Transfer Specialist )** + **Location** : Dublin CA 94568 + **Duration:** 12 months (contract extension potential) + ... knowledge of regulatory requirements and quality standards for medical device manufacturing. **Important information:** **To be immediately considered,… more