Senior Medical Device Systems Engineer | Regulatory & Risk Lead
Jobtailor
Jobtailor is seeking a Systems Engineer to drive system-level design and regulatory compliance for medical devices. You will work with electrical, software, mechanical, manufacturing, and quality engineers to ensure safe, effective products. Responsibilities include risk management per ISO 14971, design history file preparation, and cross-functional collaboration across global teams. Strong regulatory knowledge and test plan development are essential. #J-18808-Ljbffr Jobtailor
$220k - $290k
...people's lives. Our medical devices, software and... ...conditions.Job SummaryThe Senior Director, Chief Privacy Lead (CPL) serves as the... ...across Legal, Regulatory Affairs, IT, Cybersecurity... ..., and enterprise systems.The CPL is... ...role oversees privacy risk management, incident...SeniorRiskRegulatoryMinimum wageOngoing contractFull timePrivate practiceLocal areaRemote workWorldwide$102.4k - $153.55k
Job SummaryThe Senior Systems Lifecycle Engineer is a technical expert who leads and contributes to the definition... ..., requirements and risks, providing effective... ...adhere to stringent medical device regulations and... ...activities comply with regulatory requirements, including...SeniorRiskRegulatoryFull timeWork at office$94.7k - $142.1k
Job SummaryThis Senior Manufacturing Engineer role is responsible... ...cost reduction while leading equipment... ...ensure compliance with medical device quality and regulatory requirements. The... ...and review quality system documentation such... .... Willing to take risks as circumstances require...SeniorRiskRegulatoryFull timeContract workWork at officeImmediate start- ...manufacturing, and quality engineers to achieve... .... Serve as a system technical... ...refinement, performing risk reviews,... ...process. Lead risk management... ...activities comply with regulatory requirements,... .... Manage device and manufacturing... ...working in the medical device industry...SeniorRiskRegulatory
$263k - $328k
...worldwide. Could you be our next Senior Director Search & Evaluation Late TA Lead, Immunology? The job is in our... ...align with TA strategy and unmet medical needs. Co-lead internal... ...stage assets, coordinating clinical, regulatory, commercial, and market access...SeniorRegulatoryWork at officeWorldwide3 days per week$133.4k - $200.08k
...Sr. Staff Automation Engineer role is a senior technical position focused on leading automation strategy,... ...and packaging systems, drives standardization... ...ideally within the medical device industry. Position... ...performance, cost, risk, and regulatory requirements. Own and...SeniorRiskRegulatoryFull timeWork at office- First Tech Federal Credit Union is seeking a senior liquidity risk analyst to lead complex analysis and reporting related to balance sheet risk, liquidity... ...testing, CFP activation, funding negotiations, and regulatory readiness, partnering with ALCO and executives to align...SeniorRiskRegulatory
- ECI seeks a Senior Software Project Manager to oversee manufacturing software and SFMD software workstreams in a medical device integration program. You will coordinate with cross-functional teams, manage risks, and ensure regulatory compliance throughout software lifecycles...SeniorRiskRegulatory
- First Tech Federal Credit Union is seeking a Senior Liquidity Risk Analyst to lead complex balance sheet risk analyses and reporting. You will own daily... ..., contingency planning, collateral management, and regulatory interactions. #J-18808-Ljbffr First Tech Federal Credit...SeniorRiskRegulatoryTemporary work
- ...Credit Union is seeking a Director, Internal Audit - Operational Risk to lead a portfolio of risk-based assurance and advisory activities... ...audit planning, execution, reporting, issue validation, and regulatory engagement, ensuring adherence to standards #J-18808-Ljbffr...SeniorRiskRegulatory
- ...in Marlborough, MA is seeking a design engineering professional to lead development and validation of Class II electro-mechanical medical devices. You will design controls, support risk management, and collaborate with regulatory teams. This exempt role requires a Bachelor...RiskRegulatory
- First Tech is seeking an experienced risk modeling professional to support capital planning and stress testing efforts. You will develop... ..., and provide governance-ready outputs for management and regulatory reporting. The role emphasizes scenario design, data analysis,...SeniorRiskRegulatory
- ...You’ll DoThe Senior Quality Assurance... ...with global regulatory requirements and... ...GMP quality systems, CMC quality oversight... ...quality risks while... ...Pharmaceutical Sciences, Engineering, or a related... ...and medical device Quality Management... ...inclusive of market-leading benefits to...SeniorRiskRegulatoryFull timeContract workImmediate start
- ...Marlborough, MA seeks a Senior Design Engineer to lead Stop Ship activities ensuring... ...apply design controls, risk management and change... ..., validations, and regulatory submissions. The role requires... ...experience with medical device quality systems and the ability to communicate...SeniorRiskRegulatory
$104k - $120k
...Credit Union is seeking an experienced risk analyst to lead advanced balance sheet risk analyses,... ...liquidity and interest rate modeling, and regulatory reporting. You will design models,... ...deliver clear, actionable insights to senior leadership. This role is based in Massachusetts...SeniorRiskRegulatory$96k - $132k
...aerospace, defense, medical, and other... ...perspectives lead to better... ...Job PurposeThe Senior Product Quality Engineer, Consumer... ...manages quality systems, implements... ...ensure strict regulatory compliance, and... ..., Medical Device).Proven mastery... ..., and formal risk management...SeniorRiskRegulatory$220k - $290k
...people's lives. Our medical devices, software and... ...conditions.Job SummaryThe Senior Director, Global... ...& Investigations Lead serves as a key... ...including intake, risk assessment, triage... ...consistency, fairness, regulatory defensibility, and... ...to identify systemic risks, cultural concerns...SeniorRiskRegulatoryMinimum wageOngoing contractFull timeLocal areaRemote workWorldwide- Senior Audit Associate - HybridPosition OverviewThe Senior Audit Associate will play a crucial role... ...audits for our clients, ensuring compliance with regulatory requirements and internal policies. This position involves leading audit engagements, mentoring junior staff, and...SeniorRegulatory
- ...SummaryProvide quality engineering support to ensure... ...methodologies, systems and practices to... ...customer and regulatory requirements.Key... ...DutiesProvide expertise in Risk Management,... ...products.Lead MRB and Nonconformance... ...experience in OEM medical device manufacturing of...SeniorRiskRegulatoryFor subcontractorWork at office
$320k - $380k
...in people's lives. Our medical devices, software and related... ...President, Chief Compliance Lead (CCL), Americas... ...identifying and mitigating risk by developing and... ...Compliance teams and senior leaders across all divisions... ...and federal laws and regulatory requirements.Drive a...RiskRegulatoryMinimum wageOngoing contractFull timeLocal areaRemote workWorldwide- ...Hologic is seeking a Senior Supplier Quality Engineer to support our... ...quality and regulatory requirements.In... ...nonconformances, and lead data‑driven... ...working knowledge of medical device and IVD... ...validation (IQ, OQ, PQ), risk management, and... ..., measurement systems analysis (MSA, including...SeniorRiskRegulatoryWork at office
$90.22k - $188k
...opportunity for a Senior Program Manager... ...Architecture and Systems Engineering (ASE), Operational... ...schedule, performance, risk management,... ...Managers and IPT Leads to maintain acquisition... ...statutory and regulatory documentation.... ...offerings include medical, dental, 401k,...SeniorRiskRegulatoryFull timeFor contractors- ...DescriptionArtech Information Systems is the #1 Largest... ...-class talent for IT, engineering, and other... ...resources.Job DescriptionUS Regulatory Advertising and Promotion... ...strategic thinking and risk assessment for area of... ...level: Mid-Senior LevelIndustry: PharmaceuticalsSeniorRiskRegulatoryFor contractors
$204.4k - $306.55k
...organization. This senior-level position... ...and Corporate risk and business... ...:Lead and mature global... ...in executive, regulatory, audit, customer... ...support secure medical device development, threat... ...Science, Engineering, or related field... ...monitors and desktop systems (~20 pounds)....SeniorRiskRegulatoryFull timeWork at office- ...LkSG) and serves as the senior subject-matter expert... ...and the value chain. Leads the implementation,... ...applicable legal and regulatory requirements.This... ...of the human rights risk management system, and informs senior management... ...FormFresenius Medical Care is an equal opportunity...RiskRegulatoryFull timeWork at officeRemote workWork from home
- First Tech is seeking a senior quantitative risk modeler to support capital planning and stress testing by developing and maintaining analytical... ...data, and technology teams, and contribute to governance, regulatory reporting, and management action planning. #J-18808-...SeniorRiskRegulatory
- ...Responsibilities Lead and execute... ...Assurance, Quality Systems, Quality... ...interactions with regulatory agencies.... ...Collaborate with senior leadership to... ...accountability, risk management,... ...degree in science, Engineering, Quality, Life... ..., medical device, or other regulated...SeniorRiskRegulatory
$106.5k - $146k
...aerospace, defense, medical, and other... ...perspectives lead to better... ...Job PurposeThe Senior Manufacturing... ...Development Engineer will... ...quality and regulatory requirements.... ...team to assess risks and ensure that... ....g., medical device, aerospace) and... ...Exposure to ERP/MES systems,...SeniorRiskRegulatory- ...1 in 8 lifetime risk of being diagnosed... ...Lumicell is seeking a Senior Software Engineer to work in a... ...software for medical purposes. This role... ...compliance with medical device standards,... ...across hardware and system components... ...documentation to support regulatory submissions and...SeniorRiskRegulatoryFull timeCasual workImmediate startMonday to FridayAfternoon shift3 days per week
- What You’ll DoThe Senior Quality Engineer is responsible... ...the Anika Quality System and contributing... ...design control, risk management, and... ...engineering of medical devices, as well as driving... ...compliance with regulatory requirements.... ...audits; may serve as lead facilitator....SeniorRiskRegulatoryFull timeWork at officeImmediate start
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