- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...ISO 17665, etc. as well as domestic and foreign regulatory requirements; Coordinate all activities related to validations and/or… more
- Resolution Technologies, Inc. (Irvine, CA)
- …responsible for leading the design and implementation of security measures for medical device software, hardware, digital solutions and/or combinations products ... This role involves working closely with R&D, product management, regulatory , quality and compliance teams to ensure...Design: Develop and maintain a reference secure architecture for medical device products, ensuring that security is… more
- DivIHN Integration Inc (Atlanta, GA)
- …so 2-5 years of experience is acceptable. Industry experience, medical device Background in Electro-Mechanical devices are flexible Regulatory experience is ... a process for verifying compliance , matching code, interacting with any regulatory experience is useful, critical thinking, and medical devices would be… more
- Arthrex (Pendleton, SC)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... protected veteran status, or any other status protected by law.Arthrex, Inc. is a global medical device company and a leader in new product development and … more
- Arthrex (Naples, FL)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... other status protected by law.Arthrex, Inc. is a global medical device company and a leader in...Arthrex products will be printed. Support Packaging Engineering and Regulatory Affairs to develop labeling in compliance … more
- DivIHN Integration Inc (Woodland, CA)
- …Years and Area of Experience: Minimum 3 years' experience in Quality or Regulatory , preferably in a medical device , pharmaceutical or biotechnology ... for site. Responsible for new product setup, quality project management, and regulatory compliance of serum products. Ensure compliance to in-house and/or… more
- Computer World Services (CWS)Corporation (Washington, DC)
- …making the results of the activities of the OFR available to financial regulatory agencies; and assisting such member agencies in determining the types of formats ... EDR, XDR, SIEM) and Trellix HX, handle firewall management and exceptions, device management, vulnerability management and mitigation. The ideal candidate will be a… more
- Software Galaxy Systems, LLC (Danbury, CT)
- …expectations. * Develops and implements procedures, inspection procedures and test methods in compliance with QMS, Medical Device Quality System Regulation ... finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external… more
- DivIHN Integration Inc (Hayward, CA)
- …Bachelor's degree in relevant discipline or equivalent experience Experience with applicable medical device (21CFR820, ISO 13485, CMDR, MDD) and/or biologics ... and release of in-process and finished goods documentation to verify compliance to SOPs and regulatory requirement. Write, revise and review SOPs. Perform QA on… more
- Actalent (Independence, OH)
- …Hardware Engineer Job Description Design and develop new electro-stimulation medical device products. Ensure regulatory compliance . Conduct root cause ... Description - Design and development of new electro-stimulation medical device products - Regulatory compliance - Root cause analysis of products - PCB… more
- Insight Global (Raritan, NJ)
- …ISO 14971, European Medical Device Directive and European Medical Device Regulation. The regulatory compliance engineer will be expected to be on ... Job Description An employer is seeking a regulatory compliance specialist for a six...for overseeing multiple audits at a time in the medical device space. Compliance functions… more
- AbbVie (North Chicago, IL)
- …both current and emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory compliance ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting the… more
- AbbVie (Irvine, CA)
- …both current and emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory compliance ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting the… more
- ThermoFisher Scientific (Fremont, CA)
- …**REQUIREMENTS:** MINIMUM Education Requirement: Master's degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/ Compliance , Biology, ... Education and Experience Requirement: Bachelor's degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/ Compliance , Biology,… more
- Actalent (Independence, OH)
- …###@actalentservices.com Description: - Design and development of new electro-stimulation medical device products - Regulatory compliance - Root cause ... - Extensive PCB Design / Layout experience - Regulated industry - Medical device , aerospace, automotive industry - Great verbal and written communication with… more
- Actalent (Independence, OH)
- … COMPANY** Job Description Design and develop new electro-stimulation medical device products. Ensure regulatory compliance . Conduct root cause analysis ... MEDICAL PRODUCTS FOR A TOP MEDICAL DEVICE...PCB Design / Layout experience - Regulated industry - Medical device , aerospace, automotive industry - Great… more
- System One (Billerica, MA)
- …ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282) + Experience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, ... ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282) + Demonstrated ability to lead QA medical device and combination products compliance and auditing operations,… more
- Amazon (Austin, TX)
- …leadership skills? Does the thought of launching a brand new, slightly ambiguous, multifaceted regulatory compliance program excite you? If so, you may have what ... to the Amazon brand, including, but not limited to, Device Safety, FDA Compliance , and Right to...sets the vision, direction, and roadmap for the RTR regulatory program governing policy for all of Amazon's 1P… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …our team. It's a great time to be a part of ZOLL!Job SummaryThe Medical Device Cybersecurity Technical Project Manager combines technical expertise with project ... management skills to drive cybersecurity initiatives across a portfolio of medical device products. This role involves hands-on work as well as overseeing the… more
- Bausch + Lomb (Bridgewater, NJ)
- …deadlines. + Other duties as assigned. **Requirements** **TECHNICAL COMPETENCIES:** Knowledge of medical device regulatory affairs discipline throughout the ... and product specific documents for global products to ensure compliance with relevant FDA, MDR, ISO and other global...relating to submissions and regulatory approval of medical devices. Knowledge of medical device… more
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