Senior Regulatory Affairs Specialist, Medical Devices
Calyxo, Inc.
Calyxo, Inc. is looking for a Staff Regulatory Affairs Specialist in Pleasanton, California. This senior role requires 12+ years in regulatory affairs, focusing on leading complex submissions and ensuring regulatory compliance throughout product development. The ideal candidate has extensive FDA experience and a proactive mindset to navigate complex regulatory landscapes. The position offers a competitive salary, stock options, and a robust benefits package. #J-18808-Ljbffr Calyxo, Inc.
- ...Summary The Senior Regulatory Affairs Specialist supports and executes regulatory activities for medical devices across the product lifecycle, with increasing independence and responsibility. This role is responsible for developing and executing global regulatory strategies...SeniorMedical deviceWork experience placementWork at officeLocal area
$90k - $180k
...with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,0... ...treatment. The Opportunity This Senior Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart...SeniorMedical deviceFor contractorsWork experience placementWork at officeShift work- ...~5 to 6 years of Medical device Manufacturing experience (New Product Introduction - NPI) ~ Good experience in process development & process characterization ~ Good experience in Process Validations - IQ, OQ, PQ ~ Experience in test fixture design ~ Experience...SeniorMedical device
- Calyxo, Inc. in Pleasanton, California, is seeking a Senior R&D Technician to provide hands-on support in the design, testing, and manufacturing of innovative medical devices. This role is critical to product development, requiring at least 5 years of experience in a regulated...SeniorMedical deviceHourly pay
- Calyxo, Inc. in Pleasanton, CA is seeking a Senior R&D Technician to support design, testing, and manufacturing of innovative medical devices. This on-site role focuses on hands‑on prototyping, process improvement, and equipment maintenance within a regulated environment...SeniorMedical device
$140k - $150k
Calyxo, Inc., a medical device company in Pleasanton, CA, is seeking a Clinical Project Manager. In this role, you will lead the execution of clinical trials, ensuring compliance with regulations while collaborating with various stakeholders. Require a degree in life science...SeniorMedical device- ...ensuring compliance with various regulations. Candidates should have a Juris Doctor and significant experience in related fields. This opportunity offers competitive compensation and benefits as part of a global leader in medical devices. #J-18808-Ljbffr Abbott LaboratoriesSeniorMedical device
$140k - $160k
A medical device company based in Pleasanton, California, is seeking a Senior NetSuite System Administrator. In this role, you will serve as the primary administrator of the NetSuite ERP platform, optimizing order-to-cash and procure-to-pay processes. The ideal candidate...SeniorMedical device$105k - $125k
Calyxo, Inc. in Pleasanton, California, seeks a Senior Clinical Research Associate to provide operational leadership in clinical trial... ...This role includes ensuring high-quality monitoring, effective regulatory compliance, and oversight of CRAs. The ideal candidate should...SeniorMedical device$90k - $180k
Abbott Laboratories is looking for a Senior Supplier Quality Specialist in Livermore, CA. This role... ...system to ensure compliance with regulatory requirements and internal standards... ...Bachelor’s degree and experience in medical devices are required. The position offers...SeniorMedical device$90k - $180k
Abbott is seeking a Senior Supplier Quality Specialist to manage the Supplier Quality system at their Livermore... ...This role ensures compliance with regulatory requirements and internal quality... ...skills, and 5+ years of medical device related experience. Abbott offers...SeniorMedical device$130k - $140k
...managing multi-disciplinary teams. Applicants should have a BS in Engineering or Science, along with 5+ years of experience in medical device development. The role offers a competitive salary between $130,000 - $140,000, stock options, and a comprehensive benefits package...SeniorMedical device- Calyxo, Inc., based in Pleasanton, California, seeks a Senior NetSuite System Administrator to own and optimize the NetSuite ERP platform... ...accurate billing, compliance, and enhance workflows within a fast-growing medical device environment. #J-18808-Ljbffr Calyxo USA IncSeniorMedical device
$140k - $150k
Calyxo is seeking a Clinical Project Manager in Pleasanton, CA, to lead clinical trials efficiently and ensure compliance with regulatory standards. You will collaborate with internal and external partners to generate high-quality clinical evidence. Ideal candidates will...SeniorMedical device- Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 201... ...atmosphere. Summary We are seeking an accomplished Staff Regulatory Affairs Specialist to serve as a senior individual contributor and subject matter expert...Medical deviceWork at officeWorldwideShift work3 days per week
$78k - $156k
...portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Abbott Rapid Diagnostics...SeniorMedical deviceWork experience placement- ...Senior Software Systems Engineer We are seeking a Senior Software... ...of complex regulated medical technology solutions. This position... ..., validation, quality, and regulatory functions. This role requires... ...environments such as medical devices, aerospace, automotive, or similar...SeniorMedical deviceTemporary work
$140k - $155k
Think-Surgical, Inc. is seeking a Senior Software Test Engineer in Fremont, CA. The role involves testing software for a robotic... ...Computer Science, 7 years of software testing experience (including medical devices), and knowledge of industry standards. The position offers...SeniorMedical device- ...A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate...SeniorMedical device
$159.7k - $216.1k
...budgets, and maintain accurate financial records on behalf of senior leaders Support candidate experience during interview processes... ...SKILLS AND QUALIFICATIONS ~ Biotech, life sciences, medical device, or high-growth tech strongly preferred WHAT WILL SET YOU...SeniorMedical deviceFull timeWork at office- ...Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company... ...atmosphere. Summary: The Senior Clinical Research Associate (Senior CRA... ...monitoring, effective site management, regulatory compliance, and audit readiness at all...SeniorMedical deviceFull timeWork at officeRemote workShift work3 days per week
- Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound... ..., diverse atmosphere. Summary We are seeking an experienced Senior NetSuite System Administrator to serve as the subject matter...SeniorMedical deviceShift work
- Confluent Medical Technologies, Inc. is seeking a Senior Metrology Technician in Fremont, CA. This role involves developing and validating measurement processes for precision medical devices. The ideal candidate will have 8+ years of experience in metrology, with proficiency...SeniorMedical device
$90k - $180k
...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000... ...methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the...SeniorMedical deviceFor contractorsWork experience placementWorldwide$210.63k - $267.06k
...impact. Job Description We have multiple openings for Senior Mechanical Engineering Analysts . As a Senior Mechanical... ...Federal Law applies to us as a Federal Contractor. Wireless and Medical Devices Per the Department of Energy (DOE), Lawrence Livermore...SeniorMedical deviceMinimum wageFor contractorsLocal areaWork from homeRelocation packageFlexible hours1 day per week$102.6k - $222.3k
Stryker Group is seeking a Senior Product Manager, Field Marketing for Ischemic Stroke solutions in a remote role. This strategic position... ...gathering market insights to enhance business performance. Medical device experience and an MBA are preferred. Salary ranges from $102,6...SeniorMedical deviceRemote job$130k - $160k
...mission forward. As a global medical technology leader for nearly... ...the quality function a medical device design and manufacturing site... ...corporate objectives and regulatory requirements (QMSR, GMP, ISO,... ...production employees through senior management. Must possess excellent...SeniorMedical deviceHourly payWork experience placementFlexible hours$124.5k
...serious health issues today and address the medical challenges of tomorrow. We strive to... ...the IEC electrical standards for Medical Devices. Follow and support the design cycle... ...the-art designs. ~ Understanding of EMC regulatory requirements and design strategies to...SeniorMedical deviceLocal areaNight shift- ...Senior Systems Design Engineer Dublin, CA... ...system integration of the specialist areas of a product.... ...products, preferably medical electronic instruments... ...Displays, medical safety/regulatory agency compliance... ...Experience in medical device development or testing...SeniorMedical deviceWork experience placement
- ...Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team. Job Title: Senior Compliance Analyst. Location(s): Pleasanton, CA. Role Overview: The Sr. Compliance Analyst within the Office of IT...SeniorWork at office
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