- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …and submits product registrations for NRC/CA-RHB SS&DRs, CMDR licenses, RMLs, FDA, MDD/ MDR , import / export control, and others as applicable. Conducts customer ... to product registrations and customer licensing for FDA, MDSAP and EU MDR (CE Marking), and other international markets. Abilities and skills required: Certified… more
- Twist BioScience (South San Francisco, CA)
- …in Quality Assurance/Regulatory requirements in medical devices, IVD, EU IVDR/ MDR , pharmaceuticals or biotechnology industry.Experience and knowledge of Next ... Generation Sequencing, Synthetic Biology Manufacturing, and Gene Manufacturing highly desirableExperience with document management systems required.Experience with Learning Management Systems.Experience with MS Office Products required.Experience with… more
- Adventist Health (Los Angeles, CA)
- …initiatives and adherence to hospital protocols. . Additional duties include MDR rounds, participating in the resident educational lecture series and scholarly ... activities and being a part of hospital committees and GME committees. No specific procedures required Qualifications . Medical degree (MD or DO) from an accredited institution. . Completion of a residency in Internal Medicine. . Board Certified or Board… more
- Oracle (Honolulu, HI)
- …Role** Oracle Health Data Intelligence is entering a high-impact phase of ** MDR (Medical Device Regulation)** readiness and **regulatory transformation** . Over the ... compute, data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this...work that was kicked off this week in the MDR software design initiative, including: ** MDR &… more
- Palo Alto Networks (Santa Clara, CA)
- …driven problem solver to join our Unit 42 Managed Detection and Response ( MDR ) team. Our team is responsible for customers internal security monitoring, threat ... hunting, and incident response. As a MDR Manager, we will rely on you to manage...a team of leaders who overlook the Unit 42 MDR team to ensure premium delivery to our customers.… more
- Palo Alto Networks (Santa Clara, CA)
- …what the workplace can be! **Job Summary** Unit 42's Managed Detection and Response ( MDR ) service is growing fast - and we're building a customer-centric team that ... act as the front line of communication between our MDR analysts and our customers, helping bridge the gap...part of a customer-focused sub-function of the Unit 42 MDR team, dedicated to proactive communication and technical guidance… more
- Medtronic (Los Angeles, CA)
- …years of experience in Quality and/or Regulatory, including direct experience in MDR /vigilance systems implementation. OR Advanced degree with 5+ years of relevant ... experience in the same areas. **Nice to Have** + 10+ years' experience working with CAPA, Management Review, Change Control and Audit processes + Experience with TrackWise software + Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA,… more
- Veralto (MA)
- …and revenue targets through proactive engagement and collaboration with sales teams. As an MDR at TraceGains, you have the opportunity to play a key role in helping ... leading brands in the food & beverage, and CPG industries streamline their supply chains and bring better products to market faster. It's an exciting environment where you can grow your sales career, learn cutting-edge B2B strategies, and work with innovative… more
- Oracle (Madison, WI)
- …and AI-enabled population health platform. As HDI accelerates readiness for MDR (Medical Device Regulation), AI regulatory requirements, and emerging global security ... flows, and infrastructure meet strict global standards for security, privacy, MDR compliance, and AI safety. **Responsibilities** **What You Will Do** **Security… more
- Kelly Services (Horsham, PA)
- …be responsible for documenting and reviewing malfunction medical device reporting MDR data fields and assisting with end-to-end high-volume complaint handling ... to improve the accuracy, efficiency and timeliness of the complaint and MDR processes. POSITION DUTIES RESPONSIBILITIES: + Document and review malfunction MDR… more
- Medtronic (North Haven, CT)
- …regulatory approval, and postapproval phases. Navigate key Regulations and Guidance Documents including MDR Regulation (EU) 2017/745, UK MDR , FDA CFR 21, and ... Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/ MDR , ISO 13485, and ISO 14971. Position works a...medical devices, including pre-clinical, clinical, approval, and post-approval with MDR implementation; MDR Regulation (EU) 2017/745, and… more
- J&J Family of Companies (Santa Clara, CA)
- …of calcified plaque. **Position Overview** In compliance with FDA, European MDD/ MDR & other International Regulations, the Complaints Specialist I will perform ... per geography regulatory requirements for approved devices (FDA, EU MDD/ MDR , PMDA, TGA etc.) and route for approval in...+ Escalate high risk incidents to management. + Complete MDR / MDV reports in an accurate and timely manner… more
- Teleflex (Wyomissing, PA)
- …Canada License applications, European Union (EU) Medical Device Regulations ( MDR ) submissions, and other regulatory deliverables, take primary authorship ... PRINCIPAL RESPONSIBILITIES: * Support 510(k)s and associated documents, EU MDR submissions, and Health Canada license applications and amendments. *… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Author FDA submissions (eg, 510(k), Q-Sub), EU technical documentation under MDR , and other global regulatory filings. + Evaluate medical device regulations and ... to align with new regulations and standards (eg, EU MDR , IVDR, MDSAP). + Write and update standard operating...and technical file updates for CE marking under EU MDR . + Experience supporting regulatory strategy throughout the product… more
- Medtronic (Lafayette, CO)
- …timely closure of complaints in compliance with ISO 13485, FDA QSR, and MDR requirements + **Analyzes quality trends and implements corrective actions** - Identifies ... external standards (ISO 13485, FDA 21 CFR Part 820, MDR /IVDR). + **Leads audit and inspection readiness** - Prepares...device regulations: FDA 21 CFR Part 820, ISO 13485, MDR /IVDR + Experience leading internal and external audits (FDA,… more
- Actalent (Lake Forest, CA)
- …understanding of global medical device regulations (eg, FDA CFR, EU MDR ). Skills Regulatory, new product development, quality, 510(k), Project management, ... engineering, MDR , EU MDR , US FDA, regulatory submission, Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device,… more
- Latham, The Pool Company (Latham, NY)
- …with Endpoint Detection and Response (EDR), Managed Detection and Response ( MDR ), Managed Risk, and Zero Trust architectures, preferably leveraging platforms such ... You Will Do: + Monitor, analyze, and respond to security alerts from EDR/ MDR platforms. + Investigate and triage security incidents, performing root cause analysis… more
- Oracle (Carson City, NV)
- …context for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ... devices. . Knowledge of ISO 14971, IEC 62366, EU MDR /IVDR, and FDA guidance related to medical device software...Preferred: . Experience supporting regulatory submissions or audits (EU MDR , FDA 510(k), etc.). . Experience working with AI-driven… more
- Oracle (Helena, MT)
- …context for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ... devices. . Knowledge of ISO 14971, IEC 62366, EU MDR /IVDR, and FDA guidance related to medical device software...Preferred: . Experience supporting regulatory submissions or audits (EU MDR , FDA 510(k), etc.). . Experience working with AI-driven… more
- Abbott (Santa Clara, CA)
- …emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR ) and ISO 10993 series. **Principal Responsibilities** + Manage direct staff ... and maintenance of biocompatibility documents to support EU Medical Device Regulations ( MDR ) Technical Files + Manage relevant standards and regulations + Mentor… more
