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Director, Regulatory Affairs
1 week ago
Quest Diagnostics San Juan Capistrano, United StatesOverview: · **Responsibilities**: · - Manages team of regulatory and clinical professionals at the Specialist or Manager levels · - Establishes and executes regulatory and clinical strategies, in cooperation with cross-functional project teams. · - Provides guidance to staff on i ...
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Regulatory Affairs Consultant
1 week ago
Redbock - an NES Fircroft company Irvine, United StatesRegulatory Affairs Consultant · Irvine, CA · A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. · The Regu ...
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Regulatory Affairs Consultant
1 week ago
Redbock - an NES Fircroft company Irvine, United StatesA fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a · Regulatory Affairs Consultant · to support them for · approximately 3 months . The consultant will need to work · onsite at least 3 days/week . · The Regulatory Affairs Consultant will ...
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Regulatory Affairs Specialist
1 week ago
Kelly Science, Engineering, Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...
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Regulatory Affairs Specialist
1 week ago
Kelly Science, Engineering, Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional S ...
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Regulatory Affairs Specialist
1 week ago
Kelly Science Engineering Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...
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Regulatory Affairs Specialist
1 week ago
Tucker Parker Smith Group (TPS Group) Irvine, United StatesJob Title: Regulatory Affairs Specialist · Location: Irvine, CA · Schedule: Hybrid, Monday to Friday, 8 AM to 5 PM, with on-site work Tue/Thur · Duration: 1 year with potential to extend/ convert to internal FTE · no fully remote option · hourly rate of $40-45/hr · About Us: We a ...
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Regulatory Affairs Consultant
4 days ago
Redbock - an NES Fircroft company Irvine, United StatesRegulatory Affairs Consultant · Irvine, CA · A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a · Regulatory Affairs Consultant · to support them for · approximately 3 months . The consultant will need to work · onsite at least 3 days/wee ...
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Director, Regulatory Affairs
1 week ago
Tarsus Pharmaceuticals Irvine, CA, United StatesAbout the RoleThe Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval. The individual will function as the regulatory lead for the assigned projects. Exper ...
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Manager, Regulatory Affairs
2 weeks ago
AbbVie Irvine, United StatesCompany Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consist ...
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Regulatory Affairs Consultant
2 weeks ago
UnitedHealth Group Irvine, United StatesMaintain knowledge of current and impending regulations and legislation Triage and lead cross-functional teams for the implementation of complex new or existing regulatory issues, monitor, and communicate status Participate in the development of stra Regulatory Affairs, Regulator ...
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Regulatory Affairs Specialist
5 days ago
Cypress HCM Irvine, United States· 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry · Working knowledge of FDA, and CE marking requirements for IVD products is a plus · Able to work independently and with others · Able to wo ...
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Regulatory Affairs Specialist
2 weeks ago
Ledgent Technology Irvine, United StatesSummary: · The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Responsibilities: · Create regulatory submissions (exercising judgment to protect proprietary information) for finalization ...
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Regulatory Affairs Specialist
1 week ago
Compunnel Irvine, United StatesJob Description: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Responsibilities: · Create regulatory submissions (exercising judgment to protect proprietary information) for final ...
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Regulatory Affairs Specialist
1 week ago
Motion Recruitment Irvine, United StatesOur client is seeking a motivated Regulatory Affairs Specialist. · The details are mentioned below: · Key Responsibilities: · • Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track time ...
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Manager, Regulatory Affairs
4 days ago
Allergan Aesthetics Irvine, United StatesJob Description · Job DescriptionCompany Description · At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, ...
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Regulatory Affairs Coordinator
1 week ago
University Of California Irvine Irvine, United States· Job Opening ID: 66133 Reports To: Director - Clinical Research Operations Working Title: Regulatory Affairs Coordinator Department: UCI Ctr for Clinical Research Bargaining Unit: RX FLSA: Non-Exempt Payroll Job Code: Job Location: UCI Campus- Irvine Percent of Time: 100% Work ...
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Regulatory Affairs Specialist
1 week ago
Trinus Irvine, United StatesJob Description · Job DescriptionSummary: · The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Responsibilities: · Create regulatory submissions (exercising judgment to protect proprieta ...
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Regulatory Affairs Specialist
1 week ago
MyKelly Irvine, United States Full timeRegulatory Affairs Specialist · The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. The Regulatory Affairs Specialist provid ...
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Sr Regulatory Affairs
2 weeks ago
Motion Recruitment Irvine, United StatesOur client, is a Fortune 100 medical device company that specializes in critical care technology, structural heart innovation, and surgical monitoring. They have a long-standing culture of integrity, collaboration, and innovation. · Job Description: · The main function of a regul ...
Specialist, Regulatory Affairs - Irvine, United States - Edwards Lifesciences
Description
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments.Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients lives.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options.Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs.
Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.How you will make an impact:
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy.
Preparing documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissionsRepresenting the regulatory function on manufacturing and product development teams to provide input on regulatory requirements.
Strategizing and presenting alternatives for meeting regulatory requirements within regulatory affairs and cross-functionallyResolving conflicts between those requirements and development issuesAdvancing complex situations to management for guidance and training opportunitiesYou will prepare and oversee documentation packages for submission to global regulatory agenciesTracking timelines and documents milestone achievements for inclusion in regulatory submissions.
You may interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files)Providing guidance on regulatory requirements necessary for contingency planningMonitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s); proposing suggestions on utilizing regulatory updates to expedite approval processReviewing labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracyWhat youll need (Required):
Masters degree and previous related experience OR Bachelors degree and 3 years of previous related experienceCoursework, seminars and/or other formal government and/or trade association trainingWhat else we look for (Preferred):Masters degree in scientific discipline and 1 year of preparing (writing) domestic and international submissionsBachelors degree in scientific discipline and 3 years preparing (writing) domestic and international submissionsSolid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class IIISolid knowledge of global regulatory requirements for new products or product changesSolid knowledge of new product development systemsAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $70,000 to $100,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.
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