- Actalent (Centennial, CO)
- Job Title: Quality Engineering Lead - EU MDR Remediation Job Description We are seeking an experienced Quality Lead to support a high-impact EU ... requires strong leadership and collaboration skills, as the Quality Lead will oversee an offshore quality resource in Phase...regulatory standards and internal procedures. Essential Skills + Quality engineering + Remediation + EU MDR… more
- Actalent (Centennial, CO)
- Job Title: Engineering Lead - EU MDR Remediation Job Description We are seeking a skilled and proactive Engineering Lead to support a long-term ... remediation activities to ensure alignment with EU MDR requirements. In Phase 2, the Engineering ... engineering remediation of technical files to meet EU MDR standards. + Lead … more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …and technical QA staff. * Deep knowledge of global medical device regulations (FDA, EU MDR , etc.). * ASQ certification (Engineer or Manager) preferred. * Six ... regulatory requirements, supporting both new product development and sustaining engineering activities. **Responsibilities** + Lead execution of...+ 21 CFR Part 820 + MDD 93/42/EEC + MDR 2017/745 + ISO 13485 + ISO 14971 +… more
- Globus Medical, Inc. (Audubon, PA)
- …Regulatory teams (US and international) to ensure compliance with standards such as EU MDR and requirements for 3D-printed implants. + Utilize sales feedback ... can resume their lives as quickly as possible. **Key Responsibilities:** **Quality Engineering & Assurance** + Ensure all Globus products and processes meet… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Lead regulatory efforts required to follow new regulations (eg, EU MDR /IVDR, MDSAP) and other requirements including changes to international standards. ... file updates for CE marking activities and notified body interactions to maintain EU / MDR and/or EU /IVDR product registrations + Preferred experience in… more
- Medtronic (Atlanta, GA)
- …Submission Expertise:** Proven experience preparing and submitting regulatory filings to the FDA, EU MDR , and other global regulatory agencies. + **Knowledge of ... helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in...understanding of FDA requirements, FDA and MDCG guidance documents, EU MDR , ISO 14971, ISO 13485, Good… more
- Medtronic (Irvine, CA)
- …Proven history of successful 510(k) submissions or at least supporting US 510(k) filings. + ** EU MDR Knowledge:** Solid experience or knowledge of EU MDR ... and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected,… more
- Medtronic (Mounds View, MN)
- …PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation. The successful candidate will also ... helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in...cross-functional teams on regional regulatory requirements, including FDA (US), EU MDR , NMPA (China), PMDA (Japan), and… more
- J&J Family of Companies (Santa Clara, CA)
- …compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR , MDSAP, IEC 62304, IEC 62366 and IEC 60601. Provides leadership to ... for humanity. Learn more at https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job Category:**… more
- Medtronic (Los Angeles, CA)
- …regarding FCAs - Ensure compliance with applicable regulatory requirements (eg, FDA, EU MDR , Health Canada, etc.) - Partner with cross-functional teams ... helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in...of global regulatory requirements (eg, FDA 21 CFR 806, EU MDR ) for field actions/recalls + Strong… more
- Medtronic (Minneapolis, MN)
- …Submission Expertise:** Proven experience preparing and submitting regulatory filings to the FDA, EU MDR , and other global regulatory agencies. + **Knowledge of ... Regulatory Requirements:** In-depth understanding of FDA requirements, guidance documents, EU MDR , ISO 14971, ISO 13485, and other global regulatory requirements… more
- GE HealthCare (State College, PA)
- …daily **Preferred Qualifications** + In-depth knowledge of global regulatory standards (eg, FDA, EU MDR , ISO 13485, ISO 14971) + Experience conducting and ... **Job Description Summary** GE HealthCare is seeking a Lead Install Base Engineer to join our Ultrasound...State College, PA. In this role, you will provide engineering support for probe products across the installed base,… more
- Hologic (Newark, DE)
- …+ Develop and implement compliance strategies for global regulatory standards ( EU MDR , EMC/EMI, safety compliance, etc.) throughout the product ... Lead Compliance Engineer, R&D Newark, DE, United States...test plans, verification procedures, and reports. + Collaborate with engineering , marketing, systems, and manufacturing teams to implement compliance… more
- J&J Family of Companies (Santa Clara, CA)
- …in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR , MDSAP and other relevant standards/regulations. This includes supporting project ... humanity. Learn more at https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job...11137, ISO 10993, 21 CFR Part 820, MDD 93/42/EEC, EU MDR , and MDSAP required. + Working… more
- Abbott (Alameda, CA)
- …and Oversight: Ensure compliance with global regulatory standards (eg, FDA, EMA, ISO 13485, EU MDR ) and oversee internal and external audits. + Documentation and ... impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative and drive the next...regulations (eg, 21 CFR Part 820), ISO 13485, and EU MDR /IVDR. + Successful track record of… more
- Medtronic (Boston, MA)
- …Experience working across multiple business units and geographies. + Strong understanding of EU MDR , FDA, and other global regulatory requirements. + Strong ... helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in...knowledge of global regulations (eg, FDA's 21 CFR 820, EU MDR and other global regulations) and… more
- Insight Global (Bedford, MA)
- …and reporting to authorities. - Solid knowledge of medical device regulations (eg, FDA QSR, EU MDR ) and standards (eg, ISO 13485, ISO 14971, IEC 62304, IEC ... with AI/ML models. - Familiarity with international regulatory landscapes beyond FDA and EU MDR . - Demonstrated judgment in aligning compliance with business… more
- ThermoFisher Scientific (Marietta, OH)
- …Quality System + Ensure the site maintains continued compliance to ISO 13485, 21CFR820, EU MDR , Customer Requirements and others as necessary + Develop goals and ... will be given to candidates with regulatory expertise in International Standards ISO-13485:2016, EU MDR , and 21 CFR Part 820 FDA Quality Systems Regulation.… more
- Medtronic (Minneapolis, MN)
- …+ Experience in Quality/Compliance and/or Audit with medical device requirements (eg, MDSAP, EU MDR , ISO 13485) + Experience with regulated medical device ... helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in...a Medical Device (SaMD) Guidance's + ISO 14971:2019 + EU AI Act + Experience with regulated product cybersecurity… more
- Abbott (Pleasanton, CA)
- …a supervisory/managerial level. + Strong working knowledge of regulatory requirements for US, EU ( EU MDR ), and other international geographies. + Experience ... **Regulatory Knowledge/Skills:** + Anticipate regulatory obstacles and emerging issues. + Lead functional groups to complete a regulatory submission. + Regulatory… more