- ConvaTec (NJ)
- …RAPS Certification preferred + 3-5 years' experience preferred **Competencies:** + Regulatory / Quality experience in medical devices + Experience dealing ... and contribute to the company's continued success in the medical device industry. **Duties and Responsibilities** :...and submission of EU technical documentation + Experience of regulatory requirements for medical devices … more
- Kelly Services (Bridgewater, NJ)
- …for new/updated departmental procedures and processes. + Liaise with internal functions ( Quality , Regulatory , Medical Affairs, Clinical) to gather critical ... **EU- Medical Device Regulation (MDR) Specialist** Kelly(R) Science & Clinical is seeking an **EU-MDR Specialist** for our client in Bridgewater, NJ. If you're… more
- Abbott (Alameda, CA)
- …area or MBA is preferred. + 4-5+ years of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of ... of commercial regulatory requirements associated with Advertising and Promotion of medical devices . Utilize technical regulatory skills to propose… more
- Amazon (Bellevue, WA)
- …auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and ... Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory...on drug development project teams About the team The Quality & Lean, Medical Devices … more
- AbbVie (Irvine, CA)
- … objectives, both strategic and applicable regulatory requirements. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for ... oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfolio. The role oversees generation and...compliance. + Represents safety, regulatory affairs, and medical affairs in the Quality System Owner… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience ... landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards,...with stakeholders in HA and in industry for US regulatory activities for devices and combination products… more
- Abbott (Plymouth, MN)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with… more
- Stryker (Flower Mound, TX)
- …**Preferred** + Experience in Quality , Regulatory , or R&D within the medical device industry + 4 years of experience managing technical personnel or ... and continuous improvement of products and processes. + Oversee all post-market reporting, including Medical Device Reporting (MDR) and Medical Device … more
- AbbVie (Pleasanton, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Medical Device Quality Intern Overview Envision spending your ... products to protect patients worldwide. The Medical Device Combo Product Research and Development Quality ...procedures. We support the development of a variety of medical devices in the Aesthetics space, including… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Sr. Manager, Medical Device Quality Systems, is responsible for supporting ... quality management system in support of AbbVie medical devices and combination products. The role...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … 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 Quality Management Leadership Team. 2. Oversee medical device complaint processing in compliance with...(KSA)** + Thorough knowledge of standards and regulations for medical devices complaints and global adverse event… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... quality management system in support of AbbVie medical devices and combination products. The role...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- AbbVie (Irvine, CA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... quality management system in support of AbbVie medical devices and combination products. The role...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- Sutter Health (West Sacramento, CA)
- …in Northern California within the Sutter Health footprint. Responsible for Cyber Security, Medical Device Vulnerability, Medical Device Integration, and ... comprehensive action plans to address gaps and enable successful execution of medical device integration and technology advancement including testing, release… more
- Compass Group, North America (New York, NY)
- … medical devices . + Ensures all existing and future medical devices comply with medical device security requirements to ensure protection of PHI. ... Ambulatory EVS. Learn more at www.Crothall.com. Job Summary The Medical Device Integration and Cybersecurity specialist will...KPI's are met, perform audits and risk assessments of medical devices , entail responding to trouble calls,… more
- Adecco US, Inc. (Las Vegas, NV)
- … devices meet the highest standards of quality and compliance within the medical device and life sciences industries. As part of our ISO 13485 certified ... Assess finished products to ensure they meet design specifications, quality standards, and regulatory requirements prior to... Quality Inspector or similar role in the medical device or manufacturing industry. . Familiarity… more
- Mallinckrodt Pharmaceuticals (Madison, WI)
- …and efficiency. You will play a crucial part in shaping the future of medical device engineering, ensuring regulatory compliance, and fostering a culture ... processes. + Experience with complex, software-driven, electromechanical medical device products is preferred. + Familiarity with regulatory audit… 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
- ZOLL Medical Corporation (Chelmsford, MA)
- …provide innovative technologies that make a meaningful difference in people's lives. Our medical devices , software and related services are used worldwide to ... great time to be a part of ZOLL!Job SummaryThe Medical Device Cybersecurity Technical Project Manager combines...managers. Collaboration and Communication: + Work closely with R&D, quality , regulatory , and compliance teams. + Communicate… more
- Pentax Medical (Redwood City, CA)
- …Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Medical Device Assembler- Catheter Why ... JOIN Us? We are an established medical device leader that is preparing for...attention to detail and work in accordance with all quality , regulatory and safety requirements It is… more