Regulatory Specialist

4 days ago


Alameda, United States Spectraforce Technologies Full time
Title: Regulatory Specialist II
Duration: 1 year with the possibility of extension
Location: Alameda CA 94502


Experience 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 scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics.

Education: Bachelors degree

Job Description:
  • Responsible for regulatory activities, including product registrations, regulatory impact assessment, etc.
  • Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
  • Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides consultation/advice to regulatory specialist for change control and product development.
  • Provides regulatory direction/interpretation on team activities.
  • Interprets and applies regulatory understanding to support of products and teams.
  • Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation,labeling,field support.
  • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
  • Plan and execute the given tasks proactively in a timely manner.
  • Report the status to a manager weekly.
  • Keep the training records up to date to do the tasks.
  • Able to start projects immediately after internal system training.
Other
  • Knowledge of International Standards, such as ISO13485, IEC60601.
  • Knowledge of interactions between RA and other departments to pre/post-market RA activities.
  • Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
  • Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.
  • Able to manage time and projects.
  • Able to complete the tasks with minimum supervision.

CPRA: The Company is committed to complying with the California Privacy Rights Act (‘CPRA‘) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting .

  • Alameda, United States Planet Pharma Full time

    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,...


  • Alameda, California, United States Exelixis Full time

    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...


  • Alameda, United States The Fountain Group Full time

    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...


  • Alameda, California, United States Collabera Full time

    Job DescriptionCollabera is seeking a highly skilled Regulatory Affairs Associate to join our team. The ideal candidate will have a strong background in regulatory affairs, with experience in managing regulations and working with cross-functional teams.The Regulatory Affairs Associate will be responsible for:Managing regulations and working with...


  • Alameda, California, United States Abbott Laboratories Full time

    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...


  • alameda, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    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,...


  • alameda, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    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,...


  • Alameda, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    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,...


  • Alameda, United States Abbott Full time

    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...


  • Alameda, California, United States Discovery Life Sciences LLC Full time

    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...

  • Support Specialist

    1 week ago


    Alameda, United States Alameda Alliance Full time

    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....


  • Alameda, California, United States Abbott Laboratories Full time

    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...


  • Alameda, California, United States Abbott Full time

    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...


  • Alameda, United States Alameda Alliance Full time

    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...


  • Alameda, United States Alameda Alliance Full time

    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...


  • Alameda, California, United States Alameda Alliance Full time

    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...


  • Alameda, United States Alameda Alliance Full time

    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...


  • Alameda, United States Alameda Alliance Full time

    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...


  • Alameda, United States Alameda Alliance Full time

    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...


  • Alameda, United States Alameda Alliance Full time

    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...