- Cepheid (Miami, FL)
- …while working collaboratively with a wide range of new product development and post - market surveillance stakeholder groups. The essential requirements of the ... which makes everything possible.The Director, Clinical Quality and Compliance reporting to the Sr Director of Clinical Research or VP of Clinical Affairs will ensure… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …establish and lead execution of plans to optimize our global Post Market Surveillance function. This senior leader will drive cross-functional ... individual to position the organization as a leader in proactive, data-driven post market surveillance processes to ensure products remain safe and effective… more
- Hologic (Newark, DE)
- Sr . Manager Post Market Quality...and EU Medical Device Regulation (MDR). + Expertise in post - market surveillance activities such as complaint ... and ensuring customer satisfaction in a regulated industry? We're seeking a ** Senior Manager, Post - Market Quality** to lead critical post - market … more
- Hologic (Marlborough, MA)
- …the necessary skills and experience to assess potential global field actions, complaints, Post Market Surveillance activities and nonconforming events to ... QMS + Vigilance and MDR reporting, as needed + Post Market Surveillance + Nonconforming...internal stakeholders. + Consults with and provides advice to senior management on strategies and plans for regulatory product… more
- West Pharmaceutical Services (Exton, PA)
- …requirements throughout the complete development lifecycle including commercialization, sustainment, and post market surveillance activities. The incumbent ... Sr Quality Engineer Requisition ID: 68969 Date: Jun...(eg, Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities +… more
- Edwards Lifesciences (Irvine, CA)
- …responsible for managing THV's Risk Management/Product Risk assessment activities and contributing to Post - Market Surveillance . We are looking for a strong ... us and be part of our inspiring journey. This Senior Quality Engineer will be part of Edwards Lifesciences'...closely with cross-functional teams (R&D, Regulatory, Clinical, Manufacturing, and Post - Market Surveillance ) to ensure risk… more
- Medtronic (Irvine, CA)
- …Failure Mode Control Analysis, Design Failure Mode Control Analysis and CAPA; analyzes Post - market surveillance data, investigate and respond to complaints; ... will close on - 24 Jun 2025 **Position Description:** Sr . R&D Engineer for Covidien, LP (a Medtronic company)...Analysis, Design Failure Mode Control Analysis and CAPA. Analyzing post - market surveillance , investigating and responding… more
- Fresenius Medical Center (Lawrence, MA)
- …ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions ... implementation of appropriate cybersecurity measures . Evaluation of events ( post - market surveillance ) within the scope...methods and techniques for obtaining solutions. . Networks with senior internal and external personnel in own area of… more
- Medtronic (Santa Clara, CA)
- …overseeing all aspects of quality compliance, regulatory strategy, product approvals, and post - market surveillance across a rapidly growing and innovative ... Medtronic's Endoscopy Operating Unit (OU) is seeking a strategic and accomplished Sr . Director of Quality Assurance and Regulatory Affairs (QA/RA) to lead and… more
- LSI Solutions (Victor, NY)
- …and execution of statistically valid device usability evaluation protocols. + Communication of post - market surveillance and trend analysis pertinent to the ... customer is ultimately the patient. POSITION TITLE: Surgical Device Engineer II, III, Sr . SHIFT HOURS: 8:00am to 5:00pm LOCATION: Onsite at LSI Solutions in Victor,… more
- Abbott (St. Paul, MN)
- …support. **Responsibilities:** **Collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that ... Quality System element and ensuring interfaces with research and development, manufacturing, post market surveillance and clinical functions. + Interprets… more
- West Pharmaceutical Services (Cidra, PR)
- …industry (eg, Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required + Demonstrated ... Sr Quality Engineering (Compliance) Requisition ID: 69500 Date:...of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post -offer background screening and/or drug… more
- Caldera Medical (Westlake Village, CA)
- …and assess their impact on current and future product approvals. * Support post - market surveillance activities, including adverse event reporting, vigilance ... Senior Regulatory Specialist Located in Westlake Village, CA;...of Life for Women! In your role as a Sr . Regulatory specialist, you will develop and implement medical… more
- Edwards Lifesciences (Irvine, CA)
- …+ Interface with sales, marketing and quality/complaint handling organization to support post - market surveillance efforts. + Drive technical root cause ... solutions. We are seeking a highly skilled and experienced ** Senior Systems Engineer** to join our dynamic team. The...the development of complex medical devices from **concept to market ** . + Strong knowledge of **regulatory requirements** and… more
- J&J Family of Companies (Raritan, NJ)
- …plans and failure mode analysis during product development and safety signal detection and post - market surveillance post -launch. + Review and approve ... Learn more at https://www.jnj.com/medtech This position will report to the Senior Director, Medical Affairs, Biosurgery and will provide medical leadership globally… more
- Philips (Plymouth, MN)
- …Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance , manufacturing indicators, CAPAs, HHAs, etc. ... ** Sr . Design Quality Engineer** **In this role you** Serve as a core team member completing relevant Design Assurance activities on new product development projects… more
- Abbott (Plano, TX)
- …Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post - market Surveillance Group, Clinical Affairs, Risk ... have an opportunity for a **Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager** . The Clinical Risk Evaluation (CRE)...related to risk information. Reviews and gives input to Post -Marketing Surveillance Plans (PMS) and Post… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …including independently writing investigation reports and reports per auditory/regulatory needs (incl. Post market surveillance report), and review of the ... prepares periodic reports related to complaints and quality issues and supports post - market surveillance activities + Coordinates Product Quality Committee… more
- Philips (Bothell, WA)
- …10 years' experience in FDA regulated quality/regulatory environments, with a focus on Post Market Surveillance / Complaint Handling / Regulatory Reporting ... etc.) is required + You have extensive experience/knowledge of most regulations relative to Post Market Surveillance activities and reporting, such as: ISO… more
- Astellas Pharma (Northbrook, IL)
- …registries, wearable/remote monitoring data) and their applications in drug development and post - market surveillance . + Deep understanding of disease ... to generate insights that inform clinical development, regulatory strategies, and post -approval evidence needs. The VP will lead the integration of epidemiological… more
