- System One (Billerica, MA)
- …ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282) + Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, ... Title: Head of QA Medical Device Location: Billerica, MA (can...medical devices manufactured meet established specifications + Ensure compliance with established Quality Management System (QMS) and in… more
- Hologic (Newark, DE)
- …they arise during Compliance testing. **What We Expect:** + Thorough understanding of medical device compliance and safety standards. + Understanding of ... Master's Degree, 3+ Years with PhD + Experience with compliance testing in a product device field...Experience with compliance testing in a product device field and international certifications. + Experience with wireless… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …a clear understanding of the product development lifecycle. + Lead technical medical device compliance initiatives, including assessing and communicating ... and regulatory compliance . + Support technical inquiries for the medical device regulatory submissions, registrations, licenses, clearances, approvals, and… more
- ICU Medical (San Clemente, CA)
- …in providing responses to the FDA and other regulatory agencies with respect to medical device compliance . . Provides compliance guidance concerning ... System (Design Controls, CAPA, Complaints, Document Control, etc.) * Strong knowledge of medical device standards, including but not limited to: o ISO 13485… more
- ICU Medical (Lake Forest, IL)
- …in providing responses to the FDA and other regulatory agencies with respect to medical device compliance . . Provides compliance guidance concerning ... System (Design Controls, CAPA, Complaints, Document Control, etc.) . Strong knowledge of medical device standards, including but not limited to: o ISO 13485… more
- Kelly Services (Plymouth, MN)
- …next step in your regulatory affairs career, apply today and help shape the future of medical device compliance ! **Apply Now** As part of our promise to ... an exciting opportunity to make an impact in the medical device industry? We are seeking a...position for the right candidate. **Key Responsibilities:** + Ensure compliance with regulatory standards (21 CFR 820, 807, 803,… more
- Danaher Corporation (Boston, MA)
- …a plus if you also possess previous experience in: + In-depth knowledge of medical device regulations, compliance requirements, and market dynamics. + ... and dynamic Senior Director of Alliance Partnering to join HemoCue in the medical device industry. The ideal candidate will be responsible for developing,… more
- Medtronic (San Diego, CA)
- …(Git), test tools (Selenium/JUnit), CI/CD tools (Jenkins). + Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security ... reports, business correspondence and standard operating procedures. + Exposure to medical device compliance standards (such as… more
- Medtronic (Los Angeles, CA)
- …GitLab), test tools (Selenium/JUnit), CI/CD tools (Jenkins). + **Exposure to medical device compliance standards (such as ... of software development life cycle processes (waterfall/agile/DevOps) as applied within the regulated medical device industry. You will work with the core R&D… more
- Envista Holdings Corporation (Quakertown, PA)
- …Ability to work independently and with a cross functional team. **Preferred Qualifications:** + Medical device design and compliance experience. + MS degree ... operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to… more
- AbbVie (Irvine, CA)
- …Regulations. Responsibilities include: + Perform QA activities related to Combination Product and Medical Device Development + Ensure compliance with company ... primarily responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements… more
- AbbVie (Irvine, CA)
- … Device Regulations. + Perform QA activities related to Combination Product and Medical Device Development: + Ensure compliance with company policies and ... for representing Quality Assurance (QA) on cross-functional combination product and medical device development teams and executing Quality System requirements… more
- Stryker (Portage, MI)
- …of Customer sessions. + You will demonstrate growing financial acumen in project management. Medical Device Compliance : + You will mentor others in applying ... where your work not only shapes the future of medical devices but also brings smiles and relief to...industry standards, design requirements, and test strategies in compliance with regulations. + You will lead the creation… more
- Fresenius Medical Center (Lawrence, MA)
- …development process, including specification, documentation, and quality assurance + Experience in medical device safety and EMC compliance (IEC 60601, ... SCOPE** We are seeking professionals who want to bring their talents to a Medical Device Organization that works directly with the patient, at NxStage you Make A… more
- Medtronic (Mounds View, MN)
- …product landscape & state of the art industry status + Proficient knowledge of medical device industry standards, regulations compliance requirements + Basic ... improve efficiency and cost *Supports internal and external regulatory compliance audits *Actively participates in new product development to...of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003) +… 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
- Pentax Medical (Los Angeles, CA)
- …community. Position Opening: DIRECTOR, CORPORATE ACCOUNTS Why JOIN Us? We are an established medical device leader that is preparing for high growth. This means ... and drive new business. + Partner with legal and compliance to ensure business proposal are designed and executed...Director, Corporate Accounts: + Advanced knowledge of the GI medical device national and corporate accounts landscape.… more
- Rep-Lite (Hartford, CT)
- Job Title: PRN/Part-Time Clinical Specialist - Medical Device Company Overview: At our company, we believe that better decisions in patient care should be made ... of hearing loss, antibiotic use, and surgeries in children. This innovative device non-invasively views the middle ear in real-time, providing both high-quality… more
- Vyaire Medical (Tampa, FL)
- Medical Device Sales Consultant, Acute Ventilation **Help the World Breathe Easier by Collaborating with Innovative Vyaire Employees Around the World** As a ... deliver on monthly and quarterly forecasts while maintaining CRM compliance and accuracy + Focus on driving depth and...+ Three (3) plus years in sales within a medical device (healthcare) field Or 3 years… more
- ICU Medical (NY)
- *Position Summary* The Device Sales Specialist is responsible for building and maintaining relationships with key decision makers that lead to future business ... increases profitability and expands existing accounts by selling ICU Medical products and extending relationships into new areas with...areas with new accounts. As part of a regional device and technology team, Device Sales Specialists… more