Current jobs related to Regulatory Affairs Specialist - Irvine, California - Tucker Parker Smith Group (TPS Group)
-
Regulatory Affairs Specialist
3 weeks ago
Irvine, California, United States Spectraforce Technologies Full timeJob Title: Regulatory Affairs SpecialistSpectraforce Technologies is seeking a highly skilled Regulatory Affairs Specialist to support the development and implementation of the global regulatory strategy for SkinMedica products.Key Responsibilities:Review and prepare regulatory documents and labeling for cosmetic or OTC product registrations/updates.Research...
-
Regulatory Affairs Specialist
4 weeks ago
Irvine, California, United States Roth Staffing Companies Full timeRegulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Roth Staffing Companies. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical device products.Key Responsibilities:Represent the regulatory function on manufacturing...
-
Regulatory Affairs Specialist
2 weeks ago
Irvine, California, United States Orion Group Full timeJob SummaryOrion Group is seeking a highly skilled Regulatory Affairs Specialist to support the development and implementation of the global regulatory strategy for company cosmetic and OTC products.The ideal candidate will have a strong understanding of personal care product industry regulatory affairs discipline throughout the product lifecycle, including...
-
Regulatory Affairs Specialist
3 weeks ago
Irvine, California, United States Ledgent Technology Full timeJob Title: Sr Regulatory Affairs SpecialistRoth Staffing is seeking a highly skilled Sr Regulatory Affairs Specialist to join our team in Irvine, CA. This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.Job Summary:The Sr Regulatory Affairs Specialist will be...
-
Regulatory Affairs Specialist
2 months ago
Irvine, California, United States Cypress HCM Full timeRegulatory Affairs SpecialistThis is an exciting opportunity to contribute to the success of Cypress HCM, a leading biotech company. As a Regulatory Affairs Specialist, you will play a crucial role in supporting the transition to the In Vitro Diagnostic Regulation (IVDR) for our products.Key Responsibilities:Prioritize and monitor cases throughout the day,...
-
Regulatory Affairs Specialist
3 weeks ago
Irvine, California, United States Ledgent Technology Full timeJob Title: Sr Regulatory Affairs SpecialistRoth Staffing is seeking a highly skilled Sr Regulatory Affairs Specialist to join our team in Irvine, CA. This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.Job Summary:The Sr Regulatory Affairs Specialist will be...
-
Regulatory Affairs Specialist
2 weeks ago
Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full timeRegulatory Affairs SpecialistTucker Parker Smith Group (TPS Group) is seeking a skilled Regulatory Affairs Specialist to support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for a medical device client. The ideal candidate will have a strong background in regulatory affairs and experience with CE marking requirements for IVD...
-
Regulatory Affairs Specialist
3 weeks ago
Irvine, California, United States Trinus Corporation Full timeRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Trinus Corporation. As a key member of our team, you will be responsible for ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Represent regulatory interests on product development teams, providing...
-
Regulatory Affairs Specialist
3 weeks ago
Irvine, California, United States Cynet Systems Full timeJob Title: Regulatory Affairs SpecialistCynet Systems is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory function, you will provide input on regulatory requirements and ensure compliance with global regulations.Key Responsibilities:Represent the regulatory function on manufacturing and product...
-
Regulatory Affairs Specialist
3 weeks ago
Irvine, California, United States Planet Pharma Full timeJob Title: Sr. Regulatory Affairs SpecialistPlanet Pharma is seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our medical device products with global regulatory requirements.Key Responsibilities:Represent the regulatory function on...
-
Regulatory Affairs Specialist
4 weeks ago
Irvine, California, United States TalentBurst, an Inc 5000 company Full timeRegulatory Affairs Specialist Job DescriptionTalentBurst, an Inc 5000 company, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for medical devices.Key Responsibilities:Compile and maintain regulatory...
-
Regulatory Affairs Specialist
2 months ago
Irvine, California, United States Cypress HCM Full timeJob OverviewCypress HCM is seeking a highly skilled Regulatory Affairs Specialist to support our In Vitro Diagnostic Regulation (IVDR) transition activities. This is an exciting opportunity to join a leading biotech company and contribute to the success of our products.Key ResponsibilitiesPrioritize and monitor cases throughout the day, providing status...
-
Regulatory Affairs Specialist
1 month ago
Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full timeRegulatory Affairs Specialist IILocation: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.We are seeking a Regulatory Affairs Specialist to support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for a medical device client. The successful candidate will be responsible for revising technical files, attending...
-
Regulatory Affairs Professional
5 days ago
Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full timeRegulatory Affairs SpecialistJob DescriptionAt Tucker Parker Smith Group (TPS Group), we are seeking a highly skilled Regulatory Affairs Specialist to support our client's EU's In Vitro Diagnostic Regulation (IVDR) transition activities. The successful candidate will work on revising technical files, attending meetings, and supporting labeling conversion...
-
Regulatory Affairs Director
3 weeks ago
Irvine, California, United States Diality Full timeJob Title: Director of Regulatory AffairsDiality Inc, a privately held medical device company, is seeking a highly skilled Director of Regulatory Affairs to oversee the development and implementation of regulatory strategies for our innovative hemodialysis machine. As a key member of our team, you will be responsible for ensuring compliance with global...
-
Regulatory Affairs Director
3 weeks ago
Irvine, California, United States Diality Full timeJob Title: Director of Regulatory AffairsCompany Overview:Diality Inc, a privately held medical device company, is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel.Job Summary:The Director of...
-
Regulatory Affairs Director
2 weeks ago
Irvine, California, United States Diality Full timeJob Title: Regulatory Affairs DirectorCompany: Diality IncLocation: Irvine, CAJob Type: Full-timeAbout Us: Diality Inc is a privately held medical device company committed to improving the quality of life for patients with kidney disease.Job Description:We are seeking a highly experienced Regulatory Affairs Director to oversee, develop, and influence...
-
Irvine, California, United States AbbVie Full timeAbout AbbVieAbbVie is a leading global biopharmaceutical company that discovers and delivers innovative medicines and solutions to address serious health issues.Job DescriptionThe Director of Regulatory Affairs and Strategic Labeling will play a critical role in setting strategy and leading cross-functional teams to execute labeling activities for drugs,...
-
Irvine, California, United States AbbVie Full timeAbout the Role:Absorb the challenge of leading a global team of quality assurance professionals in AbbVie's Research and Development organization. As Director, Quality Assurance and Regulatory Affairs, you will be responsible for ensuring the highest standards of quality in our products and processes.Key Responsibilities:Lead the development and...
-
Regulatory Compliance Specialist
3 weeks ago
Irvine, California, United States Gable Search Group Full timeJob Title: Regulatory Compliance SpecialistJob Summary:We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Gable Search Group. The successful candidate will be responsible for providing guidance on regulatory requirements, assisting in regulatory-related projects, and ensuring compliance with FDA regulations, ISO standards,...
Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tucker Parker Smith Group (TPS Group). As a key member of our team, you will play a critical role in supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for our medical device client.
Key Responsibilities- Technical File Revisions: Revising assigned technical files to ensure compliance with the latest IVDR requirements, including generating files using the latest technical file template and presenting product information in a clear and concise manner.
- Project Coordination: Attending weekly meetings to address issues and questions regarding technical files and providing regular progress updates to the project manager.
- Labeling Conversion: Supporting the IVDR labeling conversion project, which requires cross-functional participation and weekly group meetings to follow the conversion plan.
- Tracking and Updates: Updating the labeling conversion tracking log based on manufacturing schedules, product fill dates, and change request numbers, as well as updating labeling specifications to meet IVDR requirements.
- Product Restriction: Supporting tasks to un-CE Mark selected products, tracking work until final labeling reflects desired changes, and notifying the RA SAP restriction coordinator when specific product lots need restriction.
- Additional Tasks: Updating technical file tracking logs, notifying RA Regional notifications of labeling changes, and coordinating with the RA SAP restriction coordinator as needed.
- Education: Bachelor's degree in biochemistry, biology, medical technology, or a related field.
- Experience: 3+ years of experience in RA, QA, R&D, Manufacturing, or Project Management in the IVD industry.
- Knowledge: Thorough knowledge of FDA and CE marking requirements for IVD products, as well as policies, practices, and procedures related to RA.
As a Regulatory Affairs Specialist at Tucker Parker Smith Group (TPS Group), you will have the opportunity to work with a dynamic team and contribute to the success of our medical device client. If you are a motivated and detail-oriented professional with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
