Head of Device Quality & Regulatory Strategy
Jobtailor
Jobtailor in Massachusetts seeks a senior Device Quality leader to drive quality strategy across R&D and the product lifecycle. The role oversees global regulatory compliance and governance for GxP activities, partnering with regulatory affairs and cross-functional teams. You will guide device quality programs, ensure inspections readiness, and align with FDA/EMA/ICH/ISO standards to support safe, compliant diagnostics and devices. #J-18808-Ljbffr Jobtailor
$101.6k - $152.4k
ZOLL Medical Corporation is seeking a Regulatory Affairs professional to develop and lead regulatory strategies for resuscitation products. The ideal candidate will have... ...affairs, preferably within the medical device industry, and a Bachelor’s degree. This role involves...Regulatory- Responsibilities Lead and advance the Device Quality strategy across the R&D and product lifecycle. Serve as the accountable quality leader... ..., Product Development, Global Business Unit, and Regulatory Affairs to support co‑development, validation, regulatory...RegulatoryContract work
- • Partner with the Device Regulatory Lead on assigned projects • Provide regulatory guidance and... ...sustainable medical device regulatory strategies covering stand-alone medical devices... ...with R&D, Device, Manufacturing, and Quality teams Strong written and verbal communication...Regulatory
- ...in Massachusetts to define and drive the verification strategy for medical device software and systems. This role involves leading verification... ..., risk-based testing, and ensuring compliance with regulatory and quality standards. The ideal candidate should possess 8+ years...Regulatory
- X4 Life Sciences is seeking an Operations Quality Manager to oversee manufacturing-related quality... ...with compliance to internal and regulatory standards. The ideal candidate has over 6 years of experience in medical device manufacturing quality, with at least 3 years...Regulatory
$120k - $140k
...Program Manager for their Beverly, MA location in the medical device sector. The Program Manager will oversee product development cycles... ...budgets, and mentor teams while ensuring compliance with regulatory standards. This role requires over 8 years of experience in the...Regulatory- ...commercialization. You will lead cross‑functional teams across biology, translational science, clinical development, regulatory affairs, and market access, shaping strategies for differentiated assets and value realization. The role requires 10+ years in drug development with...Regulatory
- Responsibilities Lead long‑term portfolio strategy, identifying growth opportunities, emerging technologies, and competitive dynamics... ...of healthcare markets, clinical environments, and regulatory considerations. Ability to travel as necessary to conduct business...Regulatory
- Responsibilities Partner with the Device Regulatory Lead on assigned projects Provide regulatory... ...sustainable medical device regulatory strategies covering stand‑alone medical devices... ...with R&D, Device, Manufacturing, and Quality teams Strong written and verbal...Regulatory
$120k - $140k
...timelines and along with any mitigation strategies.* Measure, report and improve... ...fixture identification and ensure quality documentation for regulatory and operational readiness.* Mentor... ....* 8+ years’ experience in Medical Device or related industry.* 6+ years’ experience...Regulatory$135k - $155k
Overview This role leads operations strategy and service design for Core Administration Business... ...times, and drive measurable cost and quality outcomes. Sales & Pursuit Leadership... ...proposed BPaaS solutions align with regulatory requirements, accreditation standards, and...RegulatoryPermanent employmentFull timeWork at officeRemote work- ...Vice President of Regulatory Affairs About the Company A pioneering medical device company developing first-in-class technologies for critical unmet clinical... ...Regulatory Affairs to spearhead the global regulatory strategy for a portfolio of Class III device programs,...Regulatory
- ...transaction banking experience, focusing on product development, commercialization, and regulatory compliance. The new hire will collaborate with various teams to drive product strategy and maintain market competitiveness while ensuring superior client advocacy. An MBA is...Regulatory
- ...seeking an AI Governance Specialist responsible for driving AI strategy and governance processes across the organization. The role... ...diverse teams to enhance AI literacy and ensuring compliance with regulatory requirements. The ideal candidate will have a Bachelor’s...Regulatory
$94.4k - $293.8k
Role Overview Our AI and Data Strategy practitioners work to create and execute an organization’s business strategy for AI and Data transformation... ...Familiarity with healthcare data, interoperability, and the regulatory environment (e.g., HIPAA, CMS) Professional Skills...RegulatoryLive inWork at officeLocal area$105k
...Technology Strategy Analyst Direct Hire | Onsite in Oklahoma City Compensation: ~$105K (DOE) + Medical, Dental, Vision, 401(k), PTO... ...scalability. Monitor industry trends, fintech innovations, and regulatory changes; summarize insights for executive audiences. Support technology...Regulatory- Jobtailor is seeking an experienced leader to drive the strategy, delivery, and ongoing optimization of finance data and analytics... ...IT to enable upgrades, cloud migrations, and automation while maintaining data quality and regulatory compliance. #J-18808-Ljbffr JobtailorRegulatory
- ...Senior / Principal Regulatory Affairs Specialist Job Description We are seeking... ...Specialist to support regulatory strategy and submissions for complex Class II and Class III medical devices. This person will work closely with R&D, Quality, Manufacturing, and Clinical...Regulatory
- ...pacemakers, defibrillators and implantable loop recorders using device company websites. Schedules appointments, imports reports,... ...administration. Maintains knowledge of hospital, department, and regulatory agency policies and requirements and participates in continuing...RegulatoryHourly payWork experience placementRemote workFlexible hoursShift workDay shift
$219k - $285k
Department: 102600 Corp Strategy & Development Location: San Diego, USA- Remote Be a part of a global team that is inspired to... ...partner to Clinical Operations, Clinical Development, Biometrics, Quality, Regulatory and Enterprise Technology and Solutions (ETS) teams. In...RegulatoryTemporary workRemote work- ...collaborate across functions such as quality, operations, R&D, Global... ...Create and sustain long‑term strategies and advise a team of managers... ...98, ISO 22442, CMDR, Medical Device Directive, and USP.... ...representing a department in regulatory inspections and communications...Regulatory
- ...development and design processes within the US Funds platform. You will coordinate inputs across stakeholders, assist in governance and regulatory disclosures, and help drive fund launches with a focus on efficiency, compliance, and client communications. The role emphasizes...Regulatory
$45.6k - $60.4k
...and compliance tasks related to end user devices. The GRC Analyst will research industry... ...and guide others. Familiarity with regulatory and compliance requirements. Understanding... ...risks and evaluating mitigation strategies. Skilled in using risk assessment and...RegulatoryMonday to Friday- ...lifecycle of market data services. You will manage vendor relationships, contract negotiations, and data usage reporting while ensuring regulatory compliance and cost efficiency. You will collaborate with investment teams, maintain systems like FITS and ServiceNow, and...RegulatoryContract work
$105k
Technology Strategy Analyst Direct Hire | Onsite in Oklahoma City Compensation: ~$105K (DOE) + Medical, Dental, Vision, 401(k), PTO *... ...RFP development. Track industry trends, fintech innovation, and regulatory changes, summarizing insights for leadership. Requirements 3-5...Regulatory$180k - $210k
...company: Viant is a global medical device partner providing design,... ...worldwide, it delivers high-quality, life‑enhancing products with... ...in short and long‑range strategy development for BCTs and Plants... ...Knowledge of FDA GMP, ISO 13485, and regulatory requirements Six Sigma Green/...RegulatoryLocal areaWorldwide- ...systems, player tracking card systems, gaming devices, safety equipment, etc.Knowledge of... ...with peers, staff members, and regulatory agency personnel.Strong written and oral... ...to task; adapt to varying customer needs.Quality: Able to maintain high standards despite...RegulatoryApprenticeship
$101.6k - $152.4k
Job Summary Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation... ...for new and sustaining products/features that result in device approval. Ensure project team colleagues, line management,...Regulatory$134k - $186k
...effective solutions to enhance quality and compliance. Serves as a... ...and key point of contact for regulatory bodies, ensuring that QMS... ...implementing robust mitigation strategies. You're the right fit if: Bachelor... .../industries such as Medical Device, Pharma, Automotive. 5+...RegulatoryWork at officeRemote workWork visaRelocation package- ...and educates their families on strategies to optimize functional independence and improve overall quality of life. Essential Work... ...techniques, modalities, and assistive devices to improve functional... ...protocols, safety guidelines, and regulatory standards to maintain a...RegulatoryTemporary workWork from home
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