![TCWGlobal](https://media.trabajo.org/img/noimg.jpg)
In Vitro Diagnostic Regulatory Specialist
3 months ago
In Vitro Diagnostic Regulatory Specialist (R&D/QA)
Irvine, CA 92618 (*Local candidates- 3 days on site/2 days remote)
$40-$45hr (Weekly pay + Benefits)
1yr contract (Excellent potential for extension or permanent)
Full-time- M-F 8am-5pm
Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives.
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.
How Youll Make An Impact:
Support the IVDR labeling conversion and revisions of technical files for all Bio-Rad Irvine products that are due to convert from the IVD Directive requirements to the new IVD Regulation.
Work cross-functionally in weekly meetings to ensure the labeling conversion follows the plan.
Monitor the monthly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional follow-ups and product restrictions, as required.
Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments.
What You Bring:
Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields
2-8 years of experience in Regulatory affairs, in Quality Assurance, R&D, Manufacturing or Project Management in IVDR (Vitro Diagnostic Regulation)
*Requires IVDR experience
Must have knowledge of FDA, and CE marking requirements for IVD products is a plus
Able to work independently and with others
Communication skills, including negotiation and persuasion.
Analytical, problem solving, computer, and critical thinking skills.
Thorough knowledge of policies, practices and procedures related to RA.
Please send your resume. Thank you
TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.
-
In Vitro Diagnostic Regulatory Specialist
1 week ago
Irvine, United States TCWGlobal Full timeJob DescriptionJob DescriptionIn Vitro Diagnostic Regulatory Specialist (R&D/QA)Irvine, CA 92618 (*Local candidates- 3 days on site/2 days remote)$40-$45hr (Weekly pay + Benefits)1yr contract (Excellent potential for extension or permanent)Full-time- M-F 8am-5pmOur client is a global team of innovators, leaders, creators, builders, and problem solvers. They...
-
In Vitro Diagnostic Regulatory Specialist
3 months ago
Irvine, United States TCWGlobal Full timeJob DescriptionJob DescriptionIn Vitro Diagnostic Regulatory Specialist (R&D/QA)Irvine, CA 92618 (*Local candidates- 3 days on site/2 days remote)$40-$45hr (Weekly pay + Benefits)1yr contract (Excellent potential for extension or permanent)Full-time- M-F 8am-5pmOur client is a global team of innovators, leaders, creators, builders, and problem solvers. They...
-
Irvine, California, United States Regulatory Affairs Professionals Society Full timeJoin Our Team as a Senior Regulatory Affairs Specialist in Critical CareFor over five decades, the Critical Care division at Regulatory Affairs Professionals Society has been at the forefront of pioneering medical advancements and enhancing patient care. Our mission is clear: we strive to ensure that every patient requiring monitoring has access to...
-
Irvine, California, United States Regulatory Affairs Professionals Society Full timeJoin Our Team:At Regulatory Affairs Professionals Society, we are dedicated to advancing the field of regulatory affairs, particularly within the Critical Care sector. Our mission is to ensure that every patient receives the highest standard of care through innovative medical technologies.Your Role:As a Senior Regulatory Affairs Specialist, you will play a...
-
Irvine, United States Regulatory Affairs Professionals Society Full timeFor over 50 years, the Critical Care product group within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology. If you're a dynamic...
-
Senior Specialist, Regulatory Affairs, Critical Care
2 months ago
Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full timeSenior Specialist, Regulatory Affairs, Critical Care Company: Edwards Lifesciences LLC Position: Req-33420 Location: Irvine, CA Posted: May 13, 2024 Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory...
-
Regulatory Compliance Specialist
1 week ago
Irvine, California, United States Jobot Full timeJoin a Leading Medical Device Company as a Regulatory Affairs SpecialistAbout the Role:We are seeking a talented and experienced Regulatory Affairs Specialist to become a vital part of our team within the medical device sector. This role is essential in maintaining our compliance with various domestic and international regulations, guidelines, and...
-
Radiology Specialist in Nuclear Medicine
1 week ago
Irvine, California, United States Ethical Search Professionals Full timePosition: Radiology Specialist in Nuclear MedicineCompany: Ethical Search ProfessionalsSalary: $110,000 to $150,000 + Comprehensive Benefits + Bonus OpportunitiesSign-On Bonus: $10,000Relocation Support: AvailableAs a key member of our healthcare team, the Radiology Specialist in Nuclear Medicine will report directly to the Nuclear Medicine Supervisor. This...
-
Irvine, California, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full timeRegulatory Affairs Senior Consultant, Critical CareCompany: Orange County Regulatory Affairs Discussion Group (OCRA)Position: Senior Regulatory Affairs SpecialistLocation: Remote/HybridOverview: Join a team dedicated to enhancing patient outcomes through innovative regulatory strategies. As a Senior Consultant in Regulatory Affairs, you will play a pivotal...
-
Diagnostic Imaging Specialist
23 hours ago
Irvine, California, United States University Of California Irvine Full timeAbout the RoleWe are seeking a highly skilled Diagnostic Imaging Specialist to join our team at the University of California, Irvine. As a key member of our diagnostic imaging department, you will be responsible for performing a wide range of diagnostic radiologic procedures using Computed Tomography (CT) technology.Key ResponsibilitiesPerform basic and...
-
Regulatory Compliance Specialist
1 week ago
Irvine, California, United States Inari Medical Full timeThe Regulatory Affairs Specialist operates with a high degree of autonomy, providing essential support to multidisciplinary teams in the formulation and implementation of regulatory strategies for innovative devices and modifications.Key Responsibilities Act as the regulatory liaison for cross-functional project teams.Develop and implement regulatory...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States myTOD, LLC Full timeSenior Regulatory Affairs Specialist Location: Irvine About OrthAlign, Inc.: OrthAlign, Inc. is a leader in Smart Technology, dedicated to transforming the medical device industry with innovative solutions that enhance patient outcomes. Our cutting-edge products are designed to meet the highest standards of quality and regulatory compliance. As a growing...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Irvine, United States myTOD, LLC Full timeSenior Regulatory Affairs SpecialistLocation: IrvineAbout OrthAlign, Inc.:OrthAlign, Inc. is a leader in Smart Technology, dedicated to transforming the medical device industry with innovative solutions that enhance patient outcomes. Our cutting-edge products are designed to meet the highest standards of quality and regulatory compliance. As a growing...
-
Senior Regulatory Affairs Specialist
4 weeks ago
Irvine, United States myTOD, LLC Full timeSenior Regulatory Affairs SpecialistLocation: IrvineAbout OrthAlign, Inc.:OrthAlign, Inc. is a leader in Smart Technology, dedicated to transforming the medical device industry with innovative solutions that enhance patient outcomes. Our cutting-edge products are designed to meet the highest standards of quality and regulatory compliance. As a growing...
-
Regulatory Compliance Specialist
4 days ago
Irvine, California, United States Brett Fisher Group - Search Consultants Full timeWhy Consider This Opportunity? Our client, a prominent manufacturer and distributor in the medical device sector, specializes in anesthesia and respiratory solutions. They are recognized for their commitment to innovation, consistently acquiring, licensing, and launching new products globally. With a presence in over 105 countries and operations across 12...
-
Regulatory Compliance Specialist
1 week ago
Irvine, California, United States Insight Global Full timeEssential Qualifications:Bachelor's Degree in a relevant fieldMinimum of 2 years' experience in regulatory compliance or complaint managementProven track record in managing the complete process of complaint resolution (initiation, investigation, and closure)Experience in preparing and submitting documentation to the FDAFamiliarity with Good Manufacturing...
-
Regulatory Affairs Specialist
2 months ago
Irvine, United States Motion Recruitment Full timeJob Title: Regulatory Affairs Specialist📍 Location: Irvine CA, Onsite📆 Duration: 6+/12+ MonthsAbout the Client:Join a global leader in the Medical Devices Industry, specializing in artificial heart valves and hemodynamic monitoring.Typical Task Breakdown:• Create regulatory submissions (exercising judgment to protect proprietary information) for...
-
Diagnostic Imaging Specialist
22 hours ago
Irvine, California, United States Providence Health & Service Full timeAbout the RoleWe are seeking a highly skilled Diagnostic Imaging Specialist to join our team at Providence Health & Service. As an Ultrasound Technologist and Senior Ultrasound Technologist, you will play a critical role in providing quality care to patients and performing US exams proficiently to provide Radiologists with accurate information to reach an...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This role is on-site. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This role is on-site. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional...