- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- Overview We are hiring a Clinical Affairs Program Manager . The Clinical Affairs Program Manager will be responsible for the development and generation of ... and in vitro diagnostic devices. In addition, the Clinical Affairs Program Manager will perform annual activities associated with Post Market Surveillance (PMS)… more
- Abbott (Santa Clara, CA)
- …in Santa Clara, CA currently has an opportunity for an on-site **Clinical Scientist/ Project Manager Clinical Evaluation** . This new team member will combine ... 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
- Integra LifeSciences (Princeton, NJ)
- …to join our team as a Project Specialist, focusing on EU MDR compliance in accordance with Design Control. This role involves developing, coordinating, ... regulatory standards and plant procedures. Primary responsibilities are to: + Support project teams by facilitating the circulation and approval of Design Control… 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
- 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 (Irvine, CA)
- …aspects of Regulatory Affairs, Submission Preparation, FDA and EU MDD/ MDR 93/42/ECC Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project ... Manager , Regulatory Affairs - Biosense Webster, Inc. -...Learn more at_ _https://www.jnj.com/.\_ **DUTIES & RESPONSIBILITIES** * Ensure compliance with global regulations and regulating agencies. Interpret the… 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 (Northridge, 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
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || ... will require security engineering. The Product Security Engineering Sr. Manager at Olympus Corporation's Digital Unit will lead a...security engineering for the Digital Unit. + Work with project leaders to assess security demands for projects and… 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
- Medtronic (Eatontown, NJ)
- …Team, leading a team of Manufacturing Engineers. If you are an experienced Engineering Manager ,this is the place for you! **A Day in the Life** Responsibilities may ... expenditures and direct/indirect labor. + Requires broad management knowledge to lead project teams in one department. Typically has mastery level knowledge and… more
- Philips (Orlando, FL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease ... of patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables...market on time. + You have detailed knowledge of MDD/ MDR , MedDev's, FDA QSR's, FDA SaMD related and cybersecurity… more
- AbbVie (Lake Bluff, IL)
- …Investigational Device Exemption (IDE) applications, Medical Devices Regulations ( MDR ), Notified Body requirements, CE Mark, In-country notifications, etc.). ... regulations and standards related to combination products and devices to ensure compliance with applicable laws and regulations related to safety and effectiveness.… more
