Regulatory Affairs Specialist

Job Summary: We are seeking a highly skilled Regulatory Affairs Policy Specialist to join our team at Exelixis. The successful candidate will be responsible for gathering and interpreting global regulatory intelligence to inform Exelixis policy and practices. Key Responsibilities: Monitor the external regulatory environment to identify emerging intelligence...

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

Job SummaryKairos Power is seeking a highly motivated and strategic professional to lead our Government Affairs team. As a key member of our organization, you will be responsible for maintaining a daily awareness of legislative developments and policy issues impacting our priorities.This role reports to the Vice President, Regulatory Affairs & Quality, and...

Actalent is a global leader in engineering and sciences services and talent solutions, driving scale, innovation, and speed to market for visionary companies. Located in a remote setting, this role is an excellent opportunity to advance your career as a Clinical Research Professional.Job Description:This Clinical Research Professional role is responsible for...

About the Opportunity:As a Post Market Surveillance Management Position, you will lead a team responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA, and Medical Device Incident reports to the rest of the world for Abbott's division products. You will be proficient with...

Job SummaryDiscovery Life Sciences LLC is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the quality and compliance of our products.Key Responsibilities:Review and approve batch records, laboratory data, standard operating procedures...

At Abbott Laboratories, we are seeking a highly skilled Software Quality Assurance Manager to join our team. This key role will be responsible for ensuring that our software and computerized systems meet regulatory and corporate requirements.Key Responsibilities:Provide quality leadership in the implementation and maintenance of software system lifecycle...

Job SummaryWe are seeking a highly skilled Software Quality Assurance Manager to join our team at Abbott. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our software products and systems.Key ResponsibilitiesProvide quality leadership and support for the implementation and maintenance of software system...

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

Credentialing Coordinator Job DescriptionJob Summary: We are seeking a highly organized and detail-oriented Credentialing Coordinator to join our team at Alameda Alliance. The successful candidate will be responsible for coordinating and maintaining the credentialing and recredentialing processes of healthcare providers and practitioners.Key...

614462Our client, a leading Medical Device company in Alameda, CA, is looking for a Regulatory Affairs Specialist II to provides consultation/advice to regulatory specialist for change control and product development.Required Skills:2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality,...

Job DescriptionJob Description·         Emerging Regulations team- manages regulations and works with cross function teams.·         Regulations can be very narrow and specific.·         Analytical, proactive, communication skills, must do research and prep work to understand regulations before meetings with...

Title: Regulatory Specialist IIDuration: 1 year with the possibility of extensionLocation: Alameda CA 94502Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or...

Details for the position are as follows:12 month contract to start with the strong possibility of extension or conversion depending on performance. Rate: $66-71 an hour. Fully onsite in Alameda, CA (open to candidates willing to relocate at their own expense. Job Description:Lead and support regulatory activities, including product registrations, impact...

The Opportunity The Principal RA Specialist – US New Product Introduction will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way...

Job Tittle: Regulatory Specialist IILocation: Alameda, CA 94502 (Onsite)Rate: $59.00/hr. on w2Duration: 1 year with the possibility of extensionsShift Time: 8:00 AM to 5:00 PMNote:1 year contract and it will renewed year by year.Regulatory Submission experience not just preparing , also submitting.Writing submission of any of the APAC countries like Japan,...

Job Tittle: Regulatory Specialist IILocation: Alameda, CA 94502 (Onsite)Rate: $59.00/hr. on w2Duration: 1 year with the possibility of extensionsShift Time: 8:00 AM to 5:00 PMNote:1 year contract and it will renewed year by year.Regulatory Submission experience not just preparing , also submitting.Writing submission of any of the APAC countries like Japan,...

Job Tittle: Regulatory Specialist IILocation: Alameda, CA 94502 (Onsite)Rate: $59.00/hr. on w2Duration: 1 year with the possibility of extensionsShift Time: 8:00 AM to 5:00 PMNote:1 year contract and it will renewed year by year.Regulatory Submission experience not just preparing , also submitting.Writing submission of any of the APAC countries like Japan,...

Summary: The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical...

Summary: The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical...

SUMMARY/JOB PURPOSE: Writes and edits various documents to support Product Development. Such documents may include clinical study reports (CSRs), common technical document (CTD) summaries for submission to regulatory agencies, protocols, Investigator Brochures, literature reviews, study manuals, and standard operating procedures (SOPs). Assembles CSR and CTD...

PRINCIPAL RESPONSIBILITIES:Under limited supervision, this position is responsible for management and coverage of the receptionist desk; serves as a customer service liaison for members, plan partners, and visitors and provides administrative support to the Operations Department. Answers and directs all incoming phone calls and greets and directs visitors....

PRINCIPLE RESPONSIBILITIES:The Member Liaison Specialist (Behavioral Health), MLS, is responsible for the intake and triage services for telephonic (call center) or online (member portal), chat, behavioral health (BH), and autism spectrum disorder (ABA) related referrals and inquiries to all care coordination programs within AAH and external provider...

PRINCIPAL RESPONSIBILITIES : The Credentialing Coordinator works under the supervision of the Manager, Peer Review and Credentialing and assists in all aspects of the Credentialing department functions. The Credentialing Coordinator is responsible for coordinating, monitoring and maintaining the credentialing and recredentialing processes of health care...

PRINCIPAL RESPONSIBILITIES:The Credentialing Coordinator works under the supervision of the Manager, Peer Review and Credentialing and assists in all aspects of the Credentialing department functions. The Credentialing Coordinator is responsible for coordinating, monitoring and maintaining the credentialing and recredentialing processes of health care...

PRINCIPAL RESPONSIBILITIES:Member Services Representatives (MSR) are the first point of contact for our members‘ primary contact with the Alliance for both routine and complex member issues with the goal of delivering excellent customer service to our customers. The position is responsible for answering a high volume of inbound and outbound calls in a...

PRINCIPAL RESPONSIBILITIES: Member Services Representatives (MSR) are the first point of contact for our members' primary contact with the Alliance for both routine and complex member issues with the goal of delivering excellent customer service to our customers. The position is responsible for answering a high volume of inbound and outbound calls in a...

PRINCIPAL RESPONSIBILITIES:Member Services Representatives (MSR) are the first point of contact for our members‘ primary contact with the Alliance for both routine and complex member issues with the goal of delivering excellent customer service to our customers. The position is responsible for answering a high volume of inbound and outbound calls in a...

PRINCIPAL RESPONSIBILITIES: Member Services Representatives (MSR) are the first point of contact for our members' primary contact with the Alliance for both routine and complex member issues with the goal of delivering excellent customer service to our customers. The position is responsible for answering a high volume of inbound and outbound calls in a...