- Abbott (Maple Grove, MN)
- …managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a ... medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance,...- Regulatory Review + EU and US medical device compliance + Project management skills… more
- Abbott (Sylmar, CA)
- …engineering, or medical fields. + 1+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of ... years' experience in a regulated industry (eg, medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class ... Collaborates with leadership in Business Unit Quality , Regulatory Affairs, R&D, Operations, Service, Medical Affairs,... Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more
- Abbott (Santa Clara, CA)
- …and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Hologic (Louisville, CO)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... **Experience** + 2-5 years in regulatory affairs, preferably within the medical device industry. + Proven experience preparing regulatory documentation… more
- J&J Family of Companies (Irvine, CA)
- …study team; o Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality / Regulatory , Medical Affairs, Medical Safety) to ... R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and.... Clinical/ medical background is a plus. . Medical device experience is highly preferred. REQUIRED… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Abbott (Plano, TX)
- …years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry. + ... guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions...and other international harmonized standards and guidelines related to medical devices , clinical studies, and quality… more
- Jabil (West Chester, PA)
- …communities around the globe. Are you experienced in Medical Device Regulatory Compliance? Jabil is seeking a qualified Quality Systems & Compliance Lead ... , you will manage, as an individual contributor, all Regulatory Compliance activities at the assigned sites. You will...exempt personnel + Knowledge of the US and international medical device quality system regulations,… more
- Merck (Wilson, NC)
- …considering patient safety and product quality . + Lead technical investigations of medical device and combination product for commercial products + Work with ... supporting regulatory inspections. + Experience in commercialization of high-volume medical device or combination products + Experience with injection… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices ... device , or pharmaceutical industry experience + Experience with both medical devices , drug- device combination products, digital health technologies… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory ...and regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more
- Lilly (Indianapolis, IN)
- …Director will provide management oversight for quality system activities performed by Quality Assurance in the medical device complaint handling area. To ... approve complaint investigations associated with use, design, and manufacturing investigations for medical devices and drug/ device combination products +… more
- Merck (West Point, PA)
- …Manufacturing Compliance, Medical Devices , Product Commercialization, Quality Management System Improvement, Regulatory Compliance, Regulatory ... managing external partners in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... properly addressed. + Contribute to internal regulatory processes and procedures for medical devices and combination products. + Engage with the relevant … more
- Gilead Sciences, Inc. (Washington, DC)
- …Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices . . **Global Regulatory ... global CMC regulatory initiatives focused on combination products and devices . Ensure regulatory conformance and consistency across markets, maintaining… more
- Trinity Health (Muskegon, MI)
- …needed to help regionalize the Cardiac Device Management program. Ensures quality and regulatory compliance related to cardiac device standards ... evidence-based practice education and competencies. * Ensures quality and regulatory compliance related to cardiac device standards using project management… more
- Philips (Plymouth, MN)
- …therapy devices , cardiovascular products, structural heart disease, and medical imaging technologies and/or experience with regulatory pathways, clinical ... **R&D Program Manager - Medical Device NPD (Plymouth, MN)** We...lead cross-functional core teams (eg, PMO, R&D, Software, Marketing, Quality , Regulatory , Industrialization, and Clinical) while managing… more
- Bausch Health (Bothell, WA)
- …progress and impact. We are seeking an Executive Director, Clinical Development for our Medical Device Aesthetics business (Solta) to be a key contributor to the ... research teams, extensive operational experience in all aspects of medical device clinical studies, and a strong...least 10 years of experience in clinical research for medical devices + At least 5 years… more
- Ricoh Americas Corporation (Indianapolis, IN)
- …Bachelor's degree in a technical field and 3+ years of experience in manufacturing quality operations medical device industry. + ISO 13485 experience ... with external agencies such registrar/notified bodies with support from Director level Quality & Regulatory personnel. Job Duties and Responsibilities **… more