We have other current jobs related to this field that you can find below

  • Business Professional

    1 month ago

    Fremont, United States Niktor LLC Full time

    Job DescriptionJob DescriptionJob Title: Regulatory Affairs SpecialistDuration: 12 MonthsLocation: Fremont, CA, 94538Exact Schedule - M-F 8am-5pm Fully onsitePay Rate: $40.00 HourlyJob Description: A Day in the Life:Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays....

  • Professional House Cleaner

    3 weeks ago

    Fremont, United States Molly Maid Full time

    Te gustara una nueva carrera donde recibas entrenamiento, y tengas la oportunidad de progresar? Quieres dejar de trabajar horas complicadas y tener cierta flexibilidad en tu horario? Te gustara controlar cunto dinero te pagan cada semana? Nuest Cleaner, Professional, Business Services, iOS, Client

  • Business Practice Professor

    6 days ago

    Fremont, California, United States San Francisco Bay University Full time

    About San Francisco Bay University: San Francisco Bay University (SFBU) is an independent, nonprofit institution accredited by WASC, located in the vibrant Silicon Valley region. We are in search of a forward-thinking and seasoned Business Practice Professor. SFBU is dedicated to transforming higher education by eliminating traditional barriers to student...

  • Business Development

    4 weeks ago

    Fremont, United States RK Logistics Group Inc Full time

    Job DescriptionJob DescriptionDescription:This full-time hybrid role as a Business Development Representative entails both remote work and onsite work at RK Logistics Group's locations in Fremont, CA. As a Business Development Representative, your primary responsibility is to drive revenue growth by identifying new business opportunities, building...

  • Business Development

    1 month ago

    Fremont, United States RK Logistics Group Inc Full time

    Job DescriptionJob DescriptionDescription:Summary:As a Business Development Sales Representative, your primary responsibility is to drive revenue growth by identifying new business opportunities, building relationships with potential clients, and converting leads into customers. You will play a crucial role in expanding the company's market presence,...

  • Business Development Manager

    3 months ago

    Fremont, United States Infoway Group Full time

    Job DescriptionJob DescriptionCompany DescriptionSince 2009, Info Way Solutions has earned a reputation as a full-service staffing firm that excels in a fast-paced marketplace. We have placed highly skilled professionals on a temporary, temporary-to-hire and direct-hire basis in the fields of accounting and finance, IT technology,office administration,...

  • Adjunct Business Instructors: Social Media, Marketing, eCommerce, Sales, Customer Relationship Analytics and Business-to-Business Management

    3 weeks ago

    Fremont, United States San Francisco Bay University Full time

    Fremont Ca Campus Adjunct Business Instructors: Social Media, Marketing, eCommerce, Sales, Customer Relationship Analytics and Business-to-Business ManagementFremont, CACategory: FacultyType: Part-timeMin. Experience: Some ExperienceSalary: $144.00 per hourTo apply, visit:...

  • Adjunct Business Instructors: Social Media, Marketing, eCommerce, Sales, Customer Relationship Analytics and Business-to-Business Management

    3 weeks ago

    Fremont, United States San Francisco Bay University Full time

    Fremont Ca Campus Adjunct Business Instructors: Social Media, Marketing, eCommerce, Sales, Customer Relationship Analytics and Business-to-Business Management Fremont, CACategory: FacultyType: Part-timeMin. Experience: Some ExperienceSalary: $144.00 per hourTo apply, visit: About San Francisco Bay University: San Francisco Bay University (SFBU), a...

  • Business Development Manager

    3 weeks ago

    Fremont, United States BIZLINK TECHNOLOGY INC Full time

    Job DescriptionJob DescriptionDescription: Develop and maintain our new business development strategy for the Healthcare Market. Help prepare the annual sales budget for new business development. Identify and develop the company’s unique selling propositions and differentiators for new customers. Help qualify opportunities.Develop proposals that speak to...

  • Business Financial Analyst

    3 months ago

    Fremont, United States Delta Electronics Americas Full time

    Delta, founded in 1971, is a global leader in switching power supplies and thermal management products with a thriving portfolio of smart energy-saving systems and solutions in the fields of industrial automation, building automation, telecom power, data center infrastructure, EV charging, renewable energy, energy storage and display, to nurture the...

  • Business Financial Analyst

    3 months ago

    Fremont, United States Delta Electronics Americas Full time

    Delta, founded in 1971, is a global leader in switching power supplies and thermal management products with a thriving portfolio of smart energy-saving systems and solutions in the fields of industrial automation, building automation, telecom power, data center infrastructure, EV charging, renewable energy, energy storage and display, to nurture the...

  • Canine Care Specialist

    5 days ago

    Fremont, California, United States Business Manager Full time

    Job OverviewDynamic and Independent Pet Care Facility is seeking a skilled Pet Groomer to join our dedicated team. This role is essential in providing top-notch grooming services to our valued clients.As a groomer, you will have the advantage of working alongside a supportive team, including receptionists and bathers, allowing you to focus entirely on your...

  • Professional Chemical Applicator for Landscaping

    5 hours ago

    Fremont, California, United States DreamScapes Landscaping & Design, Inc. Full time

    Position OverviewDreamScapes Landscaping & Design, Inc. is a premier provider of landscape management services in the North/East Metro area. Established in 1993, we are a family-owned business that prioritizes our team members.Our dedicated team of over 30 professionals is committed to delivering exceptional service to enhance our clients' properties through...

  • Squash Professional

    1 month ago

    Fremont, United States The Bay Club Full time

    Job DescriptionOur Mission The Bay Club Company is much more than a hospitality company.We provide experiences which celebrate a healthy and vibrant lifestyle. Our Culture Our unique culture is at the heart of all we do and is guided by our values and behaviors. It’s what we expect of ourselves and each other every day. We call them the “Actions We Live...

  • Business Litigation Attorney

    6 days ago

    Fremont, California, United States Gpac Full time

    A distinguished law firm is in search of a skilled associate attorney with a robust background in business and employment litigation. The ideal candidate will demonstrate outstanding communication and interpersonal abilities, alongside meticulous attention to detail, thriving in a collaborative team environment.As part of the firm's litigation team, you will...

  • Business Development Executive

    3 months ago

    Fremont, United States TD SYNNEX Full time

    About the Role Shyft Global Services. Identifies, develops, and manages multiple relationships at a corporate management level to position overall value to the organization, while providing local Shyft Global Services Acts as a direct point of contact for strategic medical technologies and is responsible for driving the strategic relationship for management...

  • Business Development Representative

    1 month ago

    Fremont, United States Aire Serv of Campbell & Saratoga Full time

    Job DescriptionJob DescriptionThis is a 100% commission only position.As a Professional Sales Associate/Home Comfort Design, you are a key member of the team who proactively generates sales and nurtures relationships. You are responsible for visiting customer homes to determine their HVAC needs and make the appropriate recommendations for system replacement....

  • Business Intelligence Analyst

    6 days ago

    Fremont, California, United States iTalent Digital Full time

    Position OverviewiTalent Digital is on the lookout for a Business Intelligence Analyst to enhance our BI, Data & Analytics team. This role is primarily client-oriented, focusing on delivering impactful insights and analytics for our prominent technology and social media partners, particularly in the areas of Facilities and Culinary operations.The selected...

  • Skilled Cosmetology Professional

    2 days ago

    Fremont, California, United States European Wax Center Full time

    European Wax Center - Immediate Opportunity for a Licensed CosmetologistCreating a Comfortable Atmosphere.Fostering Compassionate Connections.Spreading Happiness.Being True to Yourself.This is what distinguishes associates at European Wax Center.We uphold a high standard of excellence in both our services and guest interactions. Our mission is to...

  • Certified Professional Coder

    3 months ago

    Fremont, United States Washington Township Medical Foundation Full time

    Job DescriptionJob DescriptionJob Title:Certified Professional CoderJob Category:Administrative Reports To:Coding ManagerPosition Type:Full Time Position Supervisory Responsibility:This position has no supervisory responsibilitiesExempt/Non-Exempt:Non-ExemptJob DescriptionRole and ResponsibilitiesThe Certified Coding Specialist is responsible for assigned...

Business Professional

1 month ago

Fremont, United States Niktor LLC Full time
Job DescriptionJob Description

Job Title: Technical Writer II

Duration: 12 Months

Location: Fremont, CA, 94538

Exact Schedule - M-F 8am-5pm fully onsite

Pay Rate: $40.00 Hourly

Job Description:

Position Summary:

The Technical Writer II is responsible for supporting the Quality Assurance and Regulatory Affairs teams by creating, revising, and maintaining documentation related to IVDR submissions. This role works cross-functionally with Manufacturing, Operations, and Project Management teams to address documentation gaps, revise documents, submit ECOs, and maintain project timelines to meet regulatory compliance requirements.

Job Responsibilities

  • Work cross-functionally with other teams to create or revise documentation via the established document control process.
  • Review and recommend revisions or changes in scope, format, and content to existing documentation. Maintain records and files of work and revisions.
  • Work closely with Quality Assurance to ensure documentation implemented is compliant with regulatory requirements.
  • Maintain strict compliance with Quality Management System requirements, ISO 13485, cGMP, QSR and other applicable regulations and/or standards.
  • May be called upon the implement procedural changes supporting continuous improvement initiatives.
  • Respond to Quality action related to CAPAs, SCARs or nonconformances.
  • Proof-read and provide feedback on documentation prepared by other departments.
  • Organize large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage many technical documents simultaneously.
  • Ability to work independently and collaborate with cross functional teams to identify appropriate content updates as required.
  • Participate in cross functional documentation projects as required.
  • Keep functional leadership and/or project management appraised project status.
  • Additional tasks as assigned.

Ideal Candidate Preferred Qualifications

  • Effective communication skills and the ability to collaborate with cross functional teams
  • Education: B.S./B.A. in a scientific discipline (e.g. chemistry, chemical engineering, biology, bioengineering, etc.). Preference given to candidates with technical writing and scientific background.
  • Experience (minimum): 2 - 5 years' experience in a regulated environment (ISO 13485, FDA QSRs, GMP or IVDs)
  • Ability to work independently with guidance from leadership, and as part of a team;
  • Manage multiple activities, and adjust to changing priorities in a dynamic, FDA regulated environment.
  • Strong attention to detail, and ability to understand technical terminology and complex processes.
  • Experience in using an electronic Document Management System as a Technical Writer.
  • Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
  • Must be organized and detail oriented to be able to prioritize own and other's work and meet business productivity metrics.
  • Proofreading and editing skills, and an aptitude for numbers and detail-oriented work requiring a high degree of accuracy.
  • Must have excellent customer service and listening skills.
  • Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data.
  • Able to sit, stand and/or use keyboard for long periods of time.