- Merck & Co. (Rahway, NJ)
- … Device Design Control, Medical Device Management, Medical Device Regulations, Medical Devices , Medical Devices Design, Medical ... development including regulatory submission and approval processes. Including development drug- device combination product or a medical device component… more
- Merck & Co. (Rahway, NJ)
- …and design verification testing to developvalue-added solutions for medical devices and combination products.Build and enhance device or combination product ... Methodologies, Materials Engineering, Materials Science, Mechanical Engineering, Mechatronics, Medical Device Management, Medical Devices , Medical … more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …and audits. **Area of Responsibility:** + Participate in **FDA, ISO, and other regulatory inspections** related to medical devices and combination products. ... dermatology, ophthalmology and onco-dermatology. **Job Summary:** As a **QA Medical Device Specialist II** , you will...will support the QA Head in ensuring that all medical devices and combination productswhether manufactured in-house… more
- GRAIL (Durham, NC)
- …requires regular on-site presence (5 days a week) **Responsibilities:** + Support medical device Quality Engineering operations through expert ... other technical area. + Minimum of 5 years of experience working within a medical device , pharmaceutical, or biotech quality management system. + Experience… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Duties** + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health ... technologies and data-driven solutions can transform healthcare beyond traditional medical devices . This leadership role leads an...of Regulatory Affairs experience, ideally within the medical device or digital health industries. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving ... years prior regulatory affairs experience in the medical device industry, or a minimum of...sensitivity to cultural differences. + Familiarity with digital health regulatory frameworks for medical devices … more
- Olympus Corporation of the Americas (Westborough, MA)
- …solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies. + Provide regulatory guidance, ... implement, and maintain standard operating procedures (SOPs), compliance frameworks, and internal regulatory guidance specific to non- medical device digital… more
- Terumo Aortic (Sunrise, FL)
- …field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5 years direct experience ... in medical device regulatory affairs if...and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record… more
- embecta (Parsippany, NJ)
- …or technical discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + ... regulatory submissions required to market new or modified devices in both the US and Europe, and related...Must have current knowledge of the US and European Medical Device regulations. + Demonstrated success in… more
- Teleflex (Morrisville, NC)
- …a science or engineering field, or equivalent work experience. - 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 ... Senior Regulatory Affairs Specialist **Date:** Nov 3, 2025 **Location:**...- The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose… more
- Terumo Neuro (Aliso Viejo, CA)
- …writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, and/or ... focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices . Job duties:… more
- ITG Brands (Greensboro, NC)
- …US jurisdiction. + Minimum of 10 years of legal experience, in a highly regulatory industry (tobacco, pharmaceuticals, medical devices ). + Strong background ... requests and responses, including strategy, redactions, and risk mitigation. Partner with Quality and Regulatory Affairs teams to support consumer complaint… more
- Integra LifeSciences (Braintree, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … more
- Terumo Medical Corporation (Elkton, MD)
- … Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of ... the Canadian Quality System Regulation, and the Medical Device Directive. **Job Details/Responsibilities** + Manage...+ Knowledge of national and international regulations applicable to medical devices including; Quality System… more
- Olympus Corporation of the Americas (Westborough, MA)
- …subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, ... on regulations around health software development, and software for medical devices . + Collaborate on the update...Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc. + Independent… more
- Terumo Medical Corporation (Elkton, MD)
- … Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...+ Knowledge of national and international regulations applicable to medical devices including; Quality System… more
- Terumo Medical Corporation (Somerset, NJ)
- … Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of ... TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide… more
- Cordis (Irvine, CA)
- …**Responsibilities** The Quality Engineer will be responsible for ensuring that our medical devices meet the highest quality standards throughout the ... risk mitigation to ensure the safety and efficacy of medical devices . + Regulatory Compliance:...regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that processes… more
- Cordis (Irvine, CA)
- …joining the Quality team, will be responsible for ensuring that our medical devices meet the highest quality standards throughout the manufacturing ... risk mitigation to ensure the safety and efficacy of medical devices . + Regulatory Compliance:...regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing… more
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