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- ISO 19443 Nuclear Quality Systems Auditor Location: Open to Any Remote Work Location in United States HSB is a specialty insurer and accredited certification body with a long history of supporting quality, safety, and risk management across critical industries. We are seeking...SuggestedRemote work
$145k - $175k
...Description We’re looking for a driven and results-oriented sales professional to lead and build our Independent Sales Organization (ISO) partnership program. This role is highly visible and strategic with direct impact on growing relationships with ISOs, agents, and...SuggestedFull timeFlexible hoursShift work$108.4k - $154.8k
Be part of a team that unleashes the power of leading-edge technologies to help improve the health and well-being of those most vulnerable in our country and communities. Working at Gainwell carries its rewards. You’ll have an incredible opportunity to grow your career...SuggestedFull timeRemote workFlexible hours$120k - $165k
...release readiness, including release notes, user guides, and training for field application scientists and support teams, within an ISO 13485 quality system. Act as scientific subject-matter expert and contribute to roadmap planning. You profile ~ MS or PhD in...SuggestedLocal area$75k - $90k
...are a strategic partner, focused on helping clients improve products, reduce costs, and simplify operations. Certified to ISO 9001:2015, ISO 13485, and AS9100 standards, we combine quality, innovation, and growth-minded thinking to deliver real value. Job Summary...SuggestedPermanent employmentTemporary work$121.13k - $181.69k
...medical imaging software devices through ownership and application of ISO 14971-compliant risk management processes. This role provides... ...software. Working knowledge of related standards, including ISO 13485, IEC 62304, and IEC 62366-1. Knowledge of applicable regulatory...SuggestedWork at officeLocal areaRemote workWork from homeFlexible hours- ...OEM programs Strong experience within medical device manufacturing, MedTech, or regulated healthcare industries Deep knowledge of ISO 13485, FDA regulatory requirements, and medical device commercialization processes Strong understanding of injection molding, device assembly...SuggestedFull timeContract work
- ...preferred.In-depth working knowledge of the Contract Manufacturing and OEM environment and applicable regulatory requirements, including ISO 13485 and FDA requirements.5+ years of experience in account management, business development, customer success, sales, or related...SuggestedFull timeContract work
- ...regulatory compliance across the fleet — FDA, CE marking, and relevant ISO standards for autonomous systems in healthcare Develop and... ...pathways, CE marking processes, and relevant ISO standards (ISO 13485, ISO 14971, or similar) ~ Hands-on experience managing a SOC 2...SuggestedRemote jobContract work
$85.56k - $97.13k
...SEP-1 or sepsis bundle abstraction and quality reporting Familiarity with medical device quality standards such as QMSR or ISO 13485, or clear eagerness to build that knowledge Comfort reading structured clinical data exports and spreadsheets Authorization...SuggestedRemote jobFull timeTemporary workLive inLocal areaHome office$95.24k - $141.86k
...internal and external customers. Strong supplier management skills and audit experience Experience and knowledge of ISO 9001, TS16949, ISO 13485 compliance standards Physical Demands Duties of the position are performed in a manufacturing environment with...SuggestedRemote jobContract work$100k - $123k
...management Requirements Direct experience managing suppliers and contract manufacturers in regulatory environments Proficiency in ISO 13485, ISO 14971, ISO 9001, and GMP standards Competency in QMS and process audit practices with non-conformance recognition...SuggestedContract work$46.13 - $72.08 per hour
...the time ~ Excellent verbal and written communication skills ~ Strong customer relationship-building and problem-solving abilities ~ Familiarity with ISO 13485 service standards Compensation: $46.13 - $72.08/hr plus bonus, stock, and benefits eligibility...Suggested$278k - $361k
...developing and delivering FDA-regulated Software as a Medical Device solutions ~ Deep expertise in FDA regulations, IEC 62304, ISO 13485, and medical device quality systems ~ Track record leading complex, matrixed engineering organizations through growth and transformation...Suggested$147k - $163k
...or site reliability engineering practices. Experience working within regulated environments including HIPAA, FDA, CAP/CLIA, ISO 13485, or SOC 2. AWS certifications or software testing certifications are a plus. Experience leading distributed engineering...SuggestedRemote jobFull timeShift work- ...competitive landscape, collect customer feedback, and propose new product ideas Represent company at industry trade shows and maintain ISO 13485 compliance Requirements ~3–5+ years selling life science reagents and solutions ~ Demonstrated technical knowledge of...
- ...the competitive landscape, provide customer feedback, and introduce new product ideas to internal partners. - Follow regulatory and ISO 13485 requirements - Additional duties as assigned. What You’ll Bring to the Team EXPERIENCE: - Proven track record of delivering...Full time
- ...procedures. Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards Comply with and pass all requirements for...Full timeLocal areaRemote workFlexible hours
- ...Work with academic medical centers or technology transfer offices. ~ Regulated or quality-managed environments, such as GCP, ISO 13485 or FDA-regulated software. Working arrangement Remote within the United States, with travel to partners, academic centers...Permanent employmentWork at officeRemote workFlexible hours
- ...sites are situated across the US (Middleton, Petaluma, and Novato) and Europe (Berlin and Lystrup) and are underpinned by either ISO 13485 or ISO 9001 compliance. These capabilities support a wide portfolio of off-the-shelf components and kits critical to NGS workflows...Full timeFixed term contract
$82.69k
...Other: Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards. Qualifications Experience: High...Full timeWork at officeLocal areaRemote workFlexible hours$142.77k - $161.9k
...traceability, and release readiness in accordance with IEC 62304, ISO 14971, and 21 CFR 820 (QMSR) design controls. Keep the design... ...engineering, or regulatory work for software medical devices under ISO 13485 and IEC 62304, including hands-on ownership of design controls...Remote jobFull timeTemporary workFor subcontractorLive inLocal areaHome office$50 per hour
...troubleshoot Windchill issues, and recommend process improvements. Support compliance with applicable project requirements, including ISO 13485, FDA quality system requirements, 21 CFR Part 11, EU MDR, and GxP. Required Qualifications: At least 7 years of...Hourly payContract workLocal areaRemote work- ...~ Experience in CSV, SDLC, system testing, and validation documentation. ~ Knowledge of FDA requirements, 21 CFR Part 11, ISO 13485, and GxP. ~ Experience in medical devices, pharmaceuticals, or life sciences. Benefits: Employees hired into this...Full timeContract workLocal areaRemote work
$153k - $175k
...engineering. Understanding of electronics and electromechanical products used in the medical device industry, including FDA regulations, ISO 13485, MDD, risk management, and new product development processes. Experience selling complex services across a global network and...Remote jobTemporary workWork at officeLocal areaWorldwideShift workNight shift$150.5k - $245.5k
...screening, stratification, sampling, and site readiness Partner on global regulatory submissions and maintain compliance with ISO 13485, CLSI, IVDR, and GCP standards Requirements ~ PhD in molecular biology, pathology, biomedical engineering, or equivalent discipline...$127k - $165k
...field ~8-10 years US/EU regulatory affairs experience, or 6 years with Master's degree ~ Proficiency in 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, and HIPAA ~ Demonstrated experience authoring 510(k)s and managing FDA clearance processes ~ Software...$176.1k - $287.3k
...EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment. Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment). Lead cross-functional working groups, translating scientific rationale into program plans...Remote job- ...acceptance criteria, not just consumed them. Nice to Have: - Experience in regulated, clinical, or healthcare-data environments FDA, Health Canada, ISO 13485, or equivalent and comfort working with PHI. - AWS and Bedrock specifically, though any major cloud translates....Full timeWork at office
$166k - $216k
...Experience in regulated industry, preferably medical devices ~ Proficiency in C for embedded systems and familiarity with IEC 62304 and ISO 13485 ~ Strong communication, analytical, and problem-solving skills with cross-functional team experience Compensation: $166,00...