Regulatory Affairs Specialist II - Irvine, United States - Entegee

Entegee Irvine, United States

1 day ago

Description

Agile Regulatory Affairs Specialist Position

Job Overview: We are searching for a talented Regulatory Affairs Specialist to oversee the management of updates and compliance for technical files and labeling in accordance with the latest IVDR requirements, ensuring a smooth transition from the IVD Directive era.

Qualifications:

Bachelor's degree in biochemistry, biology, medical technology, or related disciplines.
3-5 years of hands-on experience in Regulatory Affairs (RA), Quality Assurance (QA), Research and Development (R&D), Manufacturing, or Project Management within the In Vitro Diagnostic (IVD) sector.
Proficiency in CE Marking and IVDR Technical Files.
Proven track record handling change requests for product labeling.

Desired Skills:

In-depth knowledge of FDA and CE marking prerequisites for IVD products.

Key Responsibilities:

Facilitate the migration of Bio-Rad products from IVD Directive standards to the cutting-edge In Vitro Diagnostic Regulation (IVDR).
Ensure labeling is updated to meet IVDR requisites and amend technical files as deemed necessary.
Collaborate across departments to ensure timely alignment during the labeling conversion process.
Supervise manufacturing timetables, oversee change requests, and assure accuracy in labeling tracking records.
Modernize previous iterations of IVDR Technical Files to the most recent template with all requisite add-ons.
Monitor RA Regional notifications and subsequent actions, as well as oversee product limitations as mandated.

Salary Range: $25.00 to $35.00 per hour

Our benefits package includes comprehensive medical, dental, vision, life, short-term disability insurance, supplementary voluntary benefits, commuter benefits, and a 401K retirement plan. Employees can select coverage options tailored to their needs. Eligible paid time off could encompass Paid Sick Leave in compliance with relevant laws, other mandated leaves, and Holiday pay based on eligibility. Please note: These benefits are not applicable to client-referred positions and direct client hirings.

Company Information

Our company specializes in bespoke automation projects and is a prominent figure in the global arena of controls and robotic solutions. Joining us will not only enrich your professional profile but also groom you into a top-tier controls engineer.

Regulatory Affairs Specialist

3 weeks ago

Kelly Science, Engineering, Technology & Telecom Irvine, United States

The Regulatory Affairs Specialist III, 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 ...
Regulatory Affairs Specialist

1 week ago

MyKelly Irvine, United States Full time

Regulatory 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 ...
Regulatory Affairs Specialist

5 days ago

Intellectt Inc Irvine, United States

Role: Regulatory Affairs Specialist · Location: Irvine, CA · Job Type: Contract · The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system. The position requires that they d ...
Regulatory Affairs Specialist

1 week 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 ...
graduate affairs specialist

3 weeks ago

University Of California Irvine Irvine, United States

· Job Opening ID: 69779 Reports To: Director of Graduate Studies Working Title: GRADUATE AFFAIRS SPECIALIST Department: SOM-Graduate Studies Bargaining Unit: 99 FLSA: Exempt Payroll Job Code: Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedule: 8-5, M-F Employee ...
Specialist, Regulatory Affairs

1 week ago

Edwards Lifesciences Irvine, United States

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 authorit ...
Specialist, Regulatory Affairs

2 weeks ago

Edwards Lifesciences Irvine, United States

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 authorit ...
Regulatory Affairs Specialist

2 weeks ago

Trinus Irvine, United States

Job Description · Job DescriptionJob 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 pro ...
Regulatory Affairs Specialist

4 days ago

Trinus Irvine, United States

Job Description · Job DescriptionJob 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 p ...
Senior Regulatory Affairs Specialist

3 weeks ago

Intellectt Inc Irvine, United States

Hello Everyone, · Greetings of the day. · This is Vydehi from Intellectt Inc. We currently have an opening for a Sr Regulatory Affairs Spec with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated r ...
Senior Regulatory Affairs Specialist

3 weeks ago

ClinChoice Irvine, United States

Position: Senior Regulatory Affairs Specialist · Employment type: 1 year Contract/ Permanent · Location: Jacksonville, FL or Irvine CA (ONSITE 2 days per week - HYBRID ROLE) · ClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical devic ...
Sr. Regulatory Affairs Specialist

3 weeks ago

Intellectt Inc Irvine, United States

Summary: · 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 finalizatio ...
Senior Regulatory Affairs Specialist

4 days ago

NeuroVasc Technologies, Inc. Irvine, United States

We are NeuroVasc Technologies We deliver excellence through innovation with integrity. · 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 execut ...
Regulatory Affairs Specialist

1 day ago

Brett Fisher Group Irvine, United States

Job Description · Job DescriptionThis is a rare opportunity to join the global regulatory team of an innovative, fast-paced, medical device company. The Company values intellectual curiosity, self-starters with a willingness to grow and expand their impact on the organization, em ...
Senior Regulatory Affairs Specialist

3 weeks ago

Intellectt Inc Irvine, United States

: Sr Regulatory Affairs Spec · : Irvine, CA · Duration: 09 Months · Must be able to speak Japanese · Job Description: · Summary: · The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. · Key Resp ...
Sr. Regulatory Affairs Specialist

1 week ago

Inari Medical Irvine, United States

· The Sr. Regulatory Affairs Specialist works under minimal supervision supporting cross- functional teams with regulatory strategy and execution for new devices and device modifications. · Responsibilities Participate as the regulatory representative supporting cross-functiona ...
Sr Regulatory Affairs Specialist

2 weeks ago

Jobot Irvine, United States

Looking for an amazing Regulatory Affairs Specialist to join a growing startup medical device company · This Jobot Job is hosted by: Aaron Erickson · Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. · Salary: $80,000 - $120,000 per y ...
Senior Regulatory Affairs Specialist

2 weeks ago

OrthAlign Irvine, United States

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient t ...
Senior Regulatory Affairs Specialist

1 day ago

OrthAlign Inc. Irvine, United States

Job Description · Job DescriptionSalary: $100k + DOE · OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, orga ...
Regulatory Affairs Specialist Temp

2 weeks ago

Nihon Kohden Irvine, United States

The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization's products. Work with RA Leadership and other members of the RA team ...