Regulatory affairs jobs in Irvine, CACreate job alerts

Prismatik Dentalcraft is a division of ___Prismatik Dentalcraft is a division of Essential Functions: - Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. - Maintains company registrations and device listings in the US, Canada, and t...

Consultant, Quality Assurance, Pharmaceutical Summary Our client, a biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with significant unmet needs, particularly in eye care, has engaged with GForce to identify a Quality Assurance consultant. T...

HSO way of working In fulfilling our roles, we are · Accountable for our own capabilities and development. · Focused on delivering results without excuses, and · Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively. ...

Title: Regulatory Affairs Specialist Reports to: VP of Quality & Regulatory Affairs Location: Remote initially then transitions to on-site (Irvine, CA office) Salary Range: $110,000 - $120,000 per year Local candidates only; no relocation will be provided for this position. The Kardion...

Job Title: Process Engineer Must Have Technical/Functional Skills • GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs • Knowledge in Experiment design and SPC • Management of statistical procedures • Strong creative...

Responsibilities - Design and provide oversight of clinical research programs for IVD products. - Build and maintain strong relationships with key opinion leaders (KOLs) and integrate their feedback into study protocols and development strategy. - Ensure clinical study design aligns with both...

InnovoCommerce is a leading software provider of AI-augmented eClinical solutions for the global life sciences industry. We’re redefining the future of pharmaceutical operations through our flagship product, Innovo Copilot, which enables pharma teams to accelerate decision-making, optimize workfl...

HSO way of working In fulfilling our roles, we are - Accountable for our own capabilities and development. - Focused on delivering results without excuses, and - Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively. ...

Job Summary - Spigen's Director of Internal Business Administration (I.B.A) oversees and manages all functions within the Human Resources, General Affairs, Finance, Logistics, IT, and Legal departments. This position holds the authority to make decisions across these key areas, ensuring efficie...

Title: Regulatory Operations Specialist Reports to: VP of Quality & Regulatory Affairs Location: Remote initially then transitions to on-site (Irvine, CA office) Salary Range: $38-41.00 per hour (Non-Exempt, $79,000 - $85,000 annualized) Local candidates only; no relocation will be prov...

Job Description JOB SUMMARY: Responsible for developing new business and maintaining profitable banking relationships with the business customers and referral sources in order to achieve Commercial/Small Business Administration lending goals. DUTIES: - Under limited supervision, develop...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionDescription: Company Overview CMBG3 Law is WOSB/WBENC certified majority women-owned nationwide law firm comprised of a diverse team of pro-active trial attorneys, litigators, lobbyists, consultants, paralegals, and staff. CMBG3 Law takes a proactive approach to solving legal prob...

Job DescriptionDescription: Company Overview CMBG3 Law is WOSB/WBENC certified majority women-owned nationwide law firm comprised of a diverse team of pro-active trial attorneys, litigators, lobbyists, consultants, paralegals, and staff. CMBG3 Law takes a proactive approach to solving legal prob...

The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that advertising and promotion activities meet geography specific regulatory requirements. The Senior Regulatory Affairs Specialist overseeing advertising and promotional Regulatory...

Represent the Regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting requirements and resolving moderately complex conflicts between requirements and development issues; also keeps management ap...

Minimum five (5) years of experience in Regulatory Affairs. Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.

Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also ke...

Provides leadership and expertise for: regulatory strategy, regulatory operations, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of Regulatory documents/statements. As Global regulatory lead (GRL), directs and supports development of ...

Regulatory Affairs Specialist II.

Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also ke...

IVD (In-vitro Diagnostics) is highly preferred.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 f...

Job DescriptionRegulatory Affairs SpecialistThis is an exciting opportunity to join an industry leading biotech company leading. The Regulatory Affairs Specialist will be responsible for supporting In Vitro Diagnostic Regulation (IVDR) transition activities that impact products currently CE Marke...

Job Description Company & Job Overview: Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. As a Staff Mechanical Engineer, you will bring deep technical expertise and leadership to our eng...

Provides leadership and expertise for: regulatory strategy, regulatory operations, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of Regulatory documents/statements. The Associate Director of Regulatory Affairs Soft Tissue Fillers supp...

Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also ke...

From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory ...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strat...

Specialist of Regulatory Affairs you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Minimum of 5 years of strong Regulatory Affa...

Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/...

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas –...

Job DescriptionOverview Allied Universal®, North America's leading security and facility services company, offers rewarding careers that provide you a sense of purpose. While working in a dynamic, welcoming, and collaborative workplace, you will be part of a team that contributes to a culture tha...

The VP of Regulatory Affairs will serve as the primary liaison with regulatory agencies and will provide strategic guidance to cross-functional teams to achieve regulatory objectives. Experience: A minimum of 15 years of regulatory affairs experience in the biopharmaceutical industry, with a prov...

Serve as Regulatory Affairs representative on project teams to develop and implement regulatory strategies for new product commercialization with key regulatory milestone, and activities for agency filing. Manager Global Regulatory Affairs shall work with a high level of autonomy to bring medical...

The Regulatory Affairs Specialist is a key partner within Regulatory Affairs and will have responsibility of the direct execution of some corporate regulatory filings. VP of Quality & Regulatory Affairs. The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is lookin...

From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Represent the Regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting ...

Serve as Regulatory Affairs representative on project teams to develop and implement regulatory strategies for new product commercialization with key regulatory milestone, and activities for agency filing. Minimum 7 years working registration experience in Regulatory Affairs in Medical Device, Op...

Minimum five (5) years of experience in Regulatory Affairs. Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.

Develop and maintain Quality and Regulatory affairs department procedures and process improvements. Job Title: Senior Manager or Director, Regulatory Affairs and Quality Assurance. Our client is seeking an experienced Regulatory Affairs Professional with strong, cross-function Quality Assurance t...

Act as primary witness on rate and regulatory related filings at the local regulatory commissions. This position is responsible for all regulatory affairs and rates related functions in multiple jurisdictions. Provide regulatory leadership and advice to direct and indirect reports to ensure regul...