- Abbott (Maple Grove, MN)
- …Clara, CA or Maple Grove, MN currently has an opportunity for a **Senior Project Manager , Clinical Evaluation** . This new team member will combine understanding ... Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745. This role will support the Structural Heart...Clinical Evaluation Reports and associated documents; set deliverable and project timelines and ensure timelines are met. + Facilitate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …impact. Join Gilead and help create possible, together. **Job Description** **Sr. Manager Quality - Combination Products, Compliance ** This opportunity is an ... to market. You will be a key Quality person managing Gilead combination products compliance . We are looking for an experienced Quality professional to ensure that we… more
- Terumo Medical Corporation (Elkton, MD)
- Manager , Quality Engineer PMS Date: Apr 12, 2024...Coordinates with the Adverse Event Reporting Specialists to ensure compliance in FDA and outside US MDR ... Terumo Interventional Systems and Terumo Medical Products. **Job Summary:** The Manager Quality Engineering, Post Market Surveillance will manage the Post Market… more
- Bausch + Lomb (Clearwater, FL)
- …standards. Supervise the product release, document control functions, training, compliance (internal auditing, supplier management and CAPA), and complaint ... Develop and monitor quality improvement and validation activities. Assure compliance to required standards through internal audits and management review,… more
- Fresenius Medical Center (Ogden, UT)
- …applicable regulatory requirements and design controls SOPs + Prepare together with Project Manager 's the design and development documentation for project ... and for design control activities. + Support Product Center/ Project Manager to get part needed to...Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier.… more
- Medtronic (Northridge, CA)
- **Careers That Change Lives** In this exciting role as a Sr. Principal Project Test Lead Engineer in the product design verification and reliability engineering ... than their predecessors. This individual will ensure that all system-level project / program work products (eg, plans, requirements, specifications, tests, test… more
- AbbVie (North Chicago, IL)
- …suppliers. Responsibilities: + With a focus on medical device suppliers, assess compliance to applicable regulations (eg, IVDR, MDR ) through supplier oversight ... Primarily responsible for providing leadership and direction and ensuring compliance with worldwide regulatory and AbbVie outsourcing requirements; providing… more
- Medtronic (Northridge, CA)
- …developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right ... support for new product introduction (NPI) and marketed products under MDD and MDR Regulation. Work with RAS, engineers, and technical experts to resolve potential… more
- J&J Family of Companies (Cincinnati, OH)
- … project scope, schedule & cost, while improving customer service, quality & compliance . The Sr Manager will provide technical mentorship and supervision to ... Sr. Lifecycle Manager -Capital Systems - 2406180074W **Description** Johnson & Johnson...meet business expectations. + Ensure projects are driven in compliance with regulatory requirements (GMP, ISO, MDR )… more
- J&J Family of Companies (Columbus, OH)
- …Reviews and Periodic Safety Updates in compliance with the EU MDR . The manager will provide leadership and maintain relationships through extensive ... Medical Writing Manager , will provide strategic oversight and governance ensuring compliance in Sci Ops functions charged with delivery of key regulatory and… more
- ICU Medical (Lake Forest, IL)
- Job Title Manager , Regulatory Affairs - Electromechanical Devices FLSA Status Exempt Work Arrangement Hybrid Position Summary The Manager , Regulatory Affairs is ... devices in the Infusion Systems business. Develop high quality US, EU MDR and global regulatory submissions that continue to build credibility with regulatory… more
- Integra LifeSciences (Plainsboro, NJ)
- …making headway to help improve outcomes. This position is for a Sr. Manager , Global Supplier Quality Systems and Strategy with hands-on experience and proven success ... candidate should demonstrate proficient experience with quality management concepts and Project Management including but not limited to supplier quality, eQMS, risk… more
- Medtronic (San Diego, CA)
- …process, make a real difference. **\#MDTDiabetesReferralCampaign** As a Software Design Quality Manager , you will lead the Software Design Quality team focused on ... + Work closely with cross functional teams and quality peers to ensure project planning is complete end-to-end, for both pre-market and post-market activities. +… more
- Medtronic (Northridge, CA)
- …and more connected. **\#MDTDiabetesReferralCampaign** In this exciting role as an Engineering Manager , you will have responsibility for managing a team of hardware ... company's design and development of new products within the portfolio. Ensures compliance in development processes. + May develop, evaluate, implement and maintain… more
- Axient (Warner Robins, GA)
- …to develop successful outcomes within established program/ project guidelines. \#CJ APPLY HERE (https://careers-axient.icims.com/jobs/5502/financial- manager ... **Axient -** DEFENSE **Overview** Axient is currently seeking a **Financial Manager ** to support our customer in **Warner Robins, GA.** **Responsibilities** **Duties… more
- Integra LifeSciences (Princeton, NJ)
- …Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized. + Carry ... Direct the activities of the GSQ department to ensure compliance with all appropriate regulations and standards, including FDA,...appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR , 21 CFR Part 11 & IQ/OQ/PQ. + Interact… more
- Kelly Services (Cuyahoga Falls, OH)
- …functions and systems to ensure continuous medical device and environmental regulatory compliance . + Assist in maintaining the Quality Management System to ensure ... corporate regulatory practices within the Quality Management System to maintain compliance with applicable regulatory agencies. + Support the development of new… more
- Zimmer Biomet (Warsaw, IN)
- …and recognized. **What You Can Expect** You have a design owner and/or project manager role with responsibility for new product design, development, and ... to design requirements and to reduce user risk in compliance with Zimmer Biomet procedures and global regulatory requirements...team with product investigations + May serve as a project manager for small scale, lower technical… more
- Zimmer Biomet (Warsaw, IN)
- …and recognized. **What You Can Expect** You have a design owner and/or project manager role with responsibility for new product design, development, and ... to design requirements and to reduce user risk in compliance with Zimmer Biomet procedures and global regulatory requirements...team with product investigations + May serve as a project manager for small scale, lower technical… more
- ConvaTec (Lexington, MA)
- …medical devices. This role encompasses preparation of regulatory dossiers, compliance maintenance, guidance provision, and fostering regulatory knowledge within the ... industry committees while contributing to process enhancements and maintaining regulatory compliance . This is a fantastic opportunity for an experienced regulatory… more