Current jobs related to Regulatory Specialist II - Alameda - Collabera

  • Regulatory Specialist II

    1 day ago

    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,...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Alameda, United States Planet Pharma Full time

    Regulatory Affairs Specialist II - APACLocation: Alameda, CA (Onsite only)Contract Duration: 12 months (with possible extension)Pay Rate: $40–56/hr. (depending on experience)Top 3 Requirements: Direct Regulatory Submissions Experience: Candidates must have hands-on experience with regulatory submissions. Experience in regulatory affairs is necessary, but...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Alameda, United States Planet Pharma Full time

    Regulatory Affairs Specialist II - APACLocation: Alameda, CA (Onsite only)Contract Duration: 12 months (with possible extension)Pay Rate: $40–56/hr. (depending on experience)Top 3 Requirements: Direct Regulatory Submissions Experience: Candidates must have hands-on experience with regulatory submissions. Experience in regulatory affairs is necessary, but...

  • Regulatory Specialist II

    4 weeks ago

    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 extensions Shift Time: 8:00 AM to 5:00 PMJob Description:Manager is looking for:Education:Bachelor’s degreeMinimum of 5 years exp.APAC regulatory submissionsExperience Background (Any):APAC regulatory submissions in Medical...

  • Regulatory Specialist II

    4 weeks ago

    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 extensions Shift Time: 8:00 AM to 5:00 PMJob Description:Manager is looking for:Education:Bachelor’s degreeMinimum of 5 years exp.APAC regulatory submissionsExperience Background (Any):APAC regulatory submissions in Medical...

  • Regulatory Specialist II

    2 months ago

    Alameda, United States Experis Full time

    Our client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. The ideal candidate should be strong in analytical skills, knowledge about requirements for APAC specifically, ability to manage projects, and time management.   Job Title: Regulatory Specialist  Location: Alameda , CA Pay...

  • Regulatory Affairs Specialist

    4 weeks ago

    Alameda, California, United States Collabera Full time

    Job Title: Regulatory Specialist IIWe are seeking a highly skilled Regulatory Specialist II to join our team at Collabera. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices and pharmaceuticals in the APAC region.Key Responsibilities:Manage regulatory activities, including...

  • Regulatory Affairs Specialist

    2 weeks ago

    Alameda, California, United States Spectraforce Technologies Full time

    Job Title: Regulatory Specialist IIAs a Regulatory Specialist II at Spectraforce Technologies, you will play a critical role in ensuring compliance with regulatory requirements for medical devices and pharmaceuticals in the APAC region. This position requires a strong understanding of regulations and standards affecting IVDs and biologics, as well as...

  • Regulatory Specialist II

    2 weeks ago

    Alameda, CA, United States Experis Full time

    Our client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. The ideal candidate should be strong in analytical skills, knowledge about requirements for APAC specifically, ability to manage projects, and time management.   Job Title: Regulatory Specialist  Location: Alameda , CA Pay...

  • APAC Submission Specialist

    1 day ago

    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,...

  • APAC Submission Specialist

    17 hours ago

    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,...

  • APAC Submission Specialist

    31 minutes ago

    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,...

  • Regulatory Specialist II

    1 month ago

    Alameda, United States Collabera Full time

    Job DescriptionJob Description·         List 3-5 hard requirements for the role: Responsible for regulatory activities, including product registrations, impact assessment, etc.Want to apply Read all the information about this position below, then hit the apply button.·         Understand country-specific requirements and deliver those to...

  • Regulatory Specialist II

    1 month ago

    Alameda, United States Collabera Full time

    Job DescriptionJob Description·         List 3-5 hard requirements for the role: Responsible for regulatory activities, including product registrations, impact assessment, etc.·         Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product...

  • Regulatory Affairs Specialist

    2 weeks ago

    Alameda, California, United States Abbott Laboratories Full time

    About AbbottAbbott 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.Job SummaryWe are seeking a highly motivated and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Alameda, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott 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.Job SummaryWe are seeking a highly...

  • Regulatory Specialist II

    1 month ago

    Alameda, United States Collabera Full time

    Job DescriptionJob Description·         Education: Bachelor’s degreeTo be considered for an interview, please make sure your application is full in line with the job specs as found below.·         Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries. Job Description...

  • Regulatory Affairs Policy Specialist

    2 weeks ago

    Alameda, California, United States Exelixis Full time

    Job SummaryWe 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 ResponsibilitiesMonitor the external regulatory environment to identify emerging intelligence with...

  • Regulatory Affairs Policy Specialist

    1 week ago

    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...

  • Principal Regulatory Affairs Specialist

    2 weeks ago

    Alameda, California, United States Abbott Laboratories Full time

    About AbbottAbbott 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.Job SummaryWe are seeking a highly skilled Principal Regulatory...

Regulatory Specialist II

2 months ago

Alameda, United States Collabera Full time
Job DescriptionJob Description

·         Education: Bachelor’s degree

·         Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.

 

Job Description (Expectation):

·         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.

·         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.

 

Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.