Current jobs related to Regulatory Affairs Specialist - Irvine - Tucker Parker Smith Group (TPS Group)
-
Regulatory Affairs Specialist
4 weeks ago
Irvine, United States Kelly Science, Engineering, Technology & Telecom Full timeRegulatory Affairs SpecialistThe 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 provides direct Worldwide Regulatory support to lifecycle management and new product...
-
Regulatory Affairs Specialist
2 months ago
Irvine, United States Kelly Science, Engineering, Technology & Telecom Full timeRegulatory Affairs SpecialistThe 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 provides direct Worldwide Regulatory support to lifecycle management and new product...
-
Regulatory Affairs Specialist
4 weeks ago
Irvine, United States Mindlance Full timeLength of Contract: 12 months 3. Location/Site: Irvine - Hybrid 4. What are the top 3-5 skills, experience or education required for this position: 1. Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations. 2. Ability to manage multiple priorities and projects with strict...
-
Regulatory Affairs Specialist
2 weeks ago
Irvine, California, United States AbbVie Full timeAbout UsAbbVie is a global leader in the development and delivery of innovative medicines and solutions that solve serious health issues. Our mission is to discover and deliver life-changing treatments that transform people's lives.Your RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible...
-
Senior Regulatory Affairs Specialist
2 months ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This On-site role reports 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 Regulatory...
-
Senior Regulatory Affairs Specialist
2 months ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This On-site role reports 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 Regulatory...
-
Regulatory Affairs Manager
2 weeks ago
Irvine, California, United States SysMind Tech Full timeDescription of Job SysMind Tech is looking for a qualified Regulatory Affairs Manager to oversee our regulatory compliance efforts. This role requires a high level of expertise in regulatory affairs, quality assurance, and compliance, with a focus on the Medical Device industry.Responsibilities: * Develop and maintain relationships with regulatory agencies,...
-
Regulatory Data Specialist
2 weeks ago
Irvine, United States Kelly Science, Engineering, Technology & Telecom Full timeJoin Kelly FSP as a RA Data Specialist on site with our Medical Device client in Irvine, CA!We are currently recruiting for a Regulatory Affairs Data Specialist to support the Regulatory Affairs team, located in Irvine, CA. The Regulatory Affairs Data Specialist will execute regulatory activities to support Regulatory Systems for our client. This role...
-
Regulatory Data Specialist
2 days ago
Irvine, United States Kelly Science, Engineering, Technology & Telecom Full timeJoin Kelly FSP as a RA Data Specialist on site with our Medical Device client in Irvine, CA!We are currently recruiting for a Regulatory Affairs Data Specialist to support the Regulatory Affairs team, located in Irvine, CA. The Regulatory Affairs Data Specialist will execute regulatory activities to support Regulatory Systems for our client. This role...
-
Regulatory Affairs Senior Manager
4 weeks ago
Irvine, California, United States Allergan Aesthetics Full timeJob SummaryAbbVie's Allergan Aesthetics is seeking a highly skilled Regulatory Affairs Senior Manager to represent regulatory affairs for device development and/or marketed product projects. The ideal candidate will have a deep understanding of US and EU medical device regulations and will be responsible for developing, communicating, and executing...
-
Irvine, California, United States Allergan Aesthetics Full timeAt Allergan Aesthetics, we strive to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.SalaryWe offer a competitive salary range of $115,000 - $150,000 per year, based on experience and qualifications.About the JobThe Sr Manager Regulatory Affairs represents...
-
Specialist, Regulatory Affairs
4 weeks ago
Irvine, United States Edwards Lifesciences Full timeDedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our...
-
Regulatory Affairs Analyst
5 days ago
Irvine, California, United States CommerceWest Bank Full timeAbout the Role: The CommerceWest Bank is seeking a Regulatory Affairs Analyst to support the implementation and maintenance of our compliance program. As a key member of the team, you will be responsible for monitoring and analyzing regulatory requirements, internal policies, and industry standards to ensure the bank operates in adherence to applicable laws...
-
Senior Counsel
5 days ago
Irvine, California, United States AbbVie Full timeAbout the Role:As a Senior Counsel - Regulatory Affairs at AbbVie, you will be responsible for delivering comprehensive legal guidance and support to internal teams within the Botox and Eye Care divisions. The ideal candidate will have 4-6 years of experience in a law firm and/or in-house legal department with expertise in regulatory affairs.You will be...
-
Irvine, California, United States Allergan Aesthetics Full timeOverviewWe are seeking a highly skilled Regulatory Affairs Lead to join our team at Allergan Aesthetics. As a key member of our regulatory affairs department, you will be responsible for developing and executing regulatory strategic plans to ensure compliance with US and EU regulations.SalaryThe estimated salary range for this position is $120,000 - $180,000...
-
Irvine, California, United States Tarsus Pharmaceuticals, Inc. Full timeTarsus Pharmaceuticals, Inc. is a forward-thinking company dedicated to delivering innovative solutions for patients. We are seeking an experienced Regulatory Affairs Professional to join our team and contribute to the development of our pharmaceutical products.As a key member of our Regulatory Affairs department, you will be responsible for managing the...
-
Senior Specialist, Regulatory Affairs
1 month ago
Irvine, United States Edwards Lifesciences Full timeDedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our...
-
Regulatory Affairs Coordinator
1 week ago
Irvine, California, United States Marquee Staffing - OC Full timeAbout the Job:">We are seeking an experienced Associate Complaint Management Specialist to join our medical device compliance team at Marquee Staffing - OC.">Job Summary:">This role involves supporting the medical device complaint-related procedures by coordinating with internal departments and external authorities.">Responsibilities:">">Record and evaluate...
-
Global Regulatory Lead, Device Development
2 weeks ago
Irvine, California, United States Allergan Aesthetics Full timeJob DescriptionWe are seeking a Global Regulatory Lead, Device Development to join our team at Allergan Aesthetics. This role will be responsible for representing regulatory affairs for device development and/or marketed product projects.ResponsibilitiesDevelops regulatory strategic plans to Global Regulatory Lead (GRL) and project teams.Ensures that...
-
Head of Quality Standards for Medical Affairs
2 weeks ago
Irvine, California, United States AbbVie Full timeKey Responsibilities:Lead the development and implementation of routine and QA oversight strategies relating to R&D business stakeholders.Collaborate with other RDQA Leaders to implement process to lead gap assessments of draft and final regulatory intelligence.Oversee the development/implementation of safety, regulatory, and medical affairs corporate...
Regulatory Affairs Specialist
4 months ago
Regulatory Affairs Specialist II
Location: Irvine, CA (Hybrid 3 days on site)
12 month Assignment
Pay Rate: $45-$49/hr.
On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE Marked under the IVD Directive.
Job Responsibilities:
- Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity.
- Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work.
- Support the IVDR labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan.
- Update the labeling conversion tracking log based on the monthly manufacturing schedule, the product fill dates, the associated product lot numbers and change requests numbers. As needed, update labeling specifications to meet the IVDR requirements.
- Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document.
- Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world.
Education and Experience:
- Bachelor's degree in biochemistry, biology, medical technology or related fields and 3+years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.
- Knowledge of FDA, and CE marking requirements for IVD products is a plus
- Thorough knowledge of policies, practices and procedures related to RA.
Please submit a copy of your resume in Word or PDF format to be considered.
