Quality Assurance and Regulatory Specialist - Tustin, CA

The Cosmetics Regulatory Operations Specialist supports Cellese's global regulatory operations through meticulous preparation of regulatory documents, · Prepare standardized regulatory document packets for all global markets, · Route final drafts to the Regulatory Manager for sig ...

The Principal Regulatory Affairs Specialist will serve as the company's primary expert for global regulatory submissions, with a strong focus on EU CE Mark and US FDA pathways for cardiac ablation catheters. · ...

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Job Title: Regulatory Affairs Specialist IIJob Description · A Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply with regulatory requirements throughout their lifecycle. This mid-level position involves a blend of strategi ...

This role will focus on supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities impacting all products currently CE Marked under the IVD Directive. · ...

Job Title: · Regulatory Affairs Specialist II · Join our client's Regulatory Affairs team to support the transition to the EU's In Vitro Diagnostic Regulation (IVDR), impacting all CE-marked IVD products. · ...

Regulatory Affairs Specialist II · Location: Irvine, CA (Hybrid – Core onsite days Tuesday & Thursday; third onsite day flexible) · Duration: 12-month contract · Pay Rate: $45–$50/hour or about $102,000 a year · Only accepting local candidates · Position Overview · This role sup ...

This role supports the European Union In Vitro Diagnostic Regulation (IVDR) transition activities impacting all Bio-Rad products currently CE-marked under the IVD Directive. · Support IVDR transition projects by revising assigned technical files using the latest approved template ...

As a Regulatory Affairs Specialist II, · you will support new product developments/product modifications, · IVDR implementation and international product. · ...

The Regulatory Coordinator I is responsible for the preparation, · organization and implementation of regulatory research documents such as pre-study activities, · initiation, execution and reporting on the various status of research tasks in accordance with FDA guidelines, · ICH ...

+This position requires support for US and EU regulatory submissions. · +Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology) · 7+ years of experience Regulatory Affairs required · +ResponsibilitiesSupport US and EU regulatory submissions (exerc ...

The Regulatory Coordinator I is responsible for the preparation and organization of regulatory research documents in accordance with FDA guidelines and SOPs. The role involves maintaining regulatory documents, coordinating investigator training, and ensuring adherence to best pra ...

As a Regulatory Affairs Specialist II you will support new product developments/product modifications IVDR implementation and international product Represent RA on global project teams for new or modified in vitro diagnostic devices IVD Manage global RA Change Request Process and ...

+We create, integrate, visualize and communicate planning concepts as they move from the initial vision through implementation. Our planning professionals build strong client partnerships, working with residents, businesses, developers, educational and medical organizations, stat ...

Description · PLANNING PRACTICE · We create, integrate, visualize and communicate planning concepts as they move from the initial vision through implementation. Our planning professionals build strong client partnerships, working with residents, businesses, developers, educationa ...

The Cosmetics Regulatory Operations Specialist supports Cellese's global regulatory operations through meticulous preparation of regulatory documents, · Maintenance of compliance records and coordination with international distributors.This role focuses on executing routine regul ...

This Senior Regulatory Affairs Specialist role supports the regulatory strategy and lifecycle management for Class II devices at a commercial-stage medical device company. The position involves hands-on experience with FDA submissions and collaboration across cross-functional tea ...

We re partnering with a growing medical device company to hire a Senior Regulatory Specialist to help drive FDA submissions and product approvals across a portfolio of Class II devices. · ...

Location: · Irvine, CA, US, 92618 · Employment Type: Salaried · Work Arrangement: Remote · Position Summary · The Senior Regulatory Compliance Specialist is responsible for supporting the implementation of the strategic food regulatory and nutrition labelling regulatory pillars a ...

Kelly Science and Clinical FSP is currently seeking a Senior Regulatory Affairs Specialist for a long-term engagement in the US with one of our Global Medical Device clients in Irvine, California. This position is hybrid, on site Monday and Wednesday. This person will join our Ke ...