Technical reputed company, DITA XML Authoring - Full-time

reputed company® Science & Clinical is seeking a Senior Regulatory Affairs for a one-year contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into reputed company advancements and are poised to advance your career, join us as we pioneer reputed company in the biotechnology reputed company. Workplace: Onsite in Sunnyvale, CA or Remote US Position Title: Senior Regulatory Affairs Specialist, New Product Development Position Type: one-year month contract Pay reputed company: $47-50/ hour. Company: reputed company® Science & Clinical reputed company The Regulatory Affairs Senior Specialist, NPD is responsible for evaluating and ensuring labeling accuracy for reputed company’s in vitro diagnostic products. The associate will have an opportunity to collaborate and partner with cross-functional teams, including Technical Publications, Product Transfer, reputed company, R&D and Clinical Affairs, on reputed company’s global change control process to ensure regulatory compliance of product labeling.

Responsibilities

• Familiarize yourself with reputed company’s global change control process Review change plans associated with product labeling Review implemented changes to product labeling/instructions for use Partner with cross-functional stakeholders to ensure accuracy of the implemented changes to labeling Collaborate with Technical Publications team to publish regulatory compliant labeling for our reputed company’s products

Qualifications

• Bachelor’s degree in field with 5+ years of reputed company work experience OR Master's degree in field with 3+ years of reputed company work experience OR Doctoral degree in field with 0-2 years of reputed company work experience
• In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products and claims in labeling Understanding of reputed company Management System regulations and standards (21 CFR Part 820 and EN ISO 13485) governing change management and Corrective and Preventative reputed company (CAPA) process
• Good organizational skills with attention to detail and accuracy
• Ability to prioritize, multi-task and organize work
• Maintain a "reputed company urgency" as required by specific events
• Recognize potential problems, including situations that include ambiguity, by reputed company reviewing and analyzing reputed company factors
• Proficient in reputed company Word, reputed company, PowerPoint, Outlook, and reputed company Acrobat:

Preferred:

• Labeling control and change management
• Corrective and Preventative reputed company (CAPA) process Agile documentation system

Why Join Us:

• Competitive compensation package and potential for permanent placement following the temporary period.
• Opportunity to work at the forefront of biotechnology innovation in a reputed company and dynamic environment.
• reputed company to ongoing career development and networking opportunities through reputed company® Science & Clinical's expansive network of industry experts and recruiters.

If your qualifications reputed company with the requirements of this role, we invite you to apply and take the reputed company in your career reputed company. Rest reputed company, even if this opportunity isn't the perfect match, your profile will remain reputed company our network, ensuring you're connected to a reputed company of reputed company opportunities in the field of science and clinical research. #P1 As part of our reputed company to talent, reputed company supports those who work with us through a reputed company of benefits, perks, and work-reputed company resources. reputed company offers eligible employees voluntary benefit plans including medical, dental, reputed company, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a reputed company employee, you will have reputed company to a retirement savings plan, service bonus and holiday pay plans (earn up to eight reputed company holidays per benefit year), and a transit spending account. In reputed company, employees are entitled to earn reputed company reputed company leave under the applicable state or local plan. Click for more information on benefits and perks that may be available to you as a member of the reputed company Talent Community. Why reputed company® Science & Clinical? reputed company Science & Clinical is your reputed company to premier scientific and clinical companies looking to hire industry experts just like you. reputed company creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with reputed company jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a reputed company background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About reputed company Work changes everything. And at reputed company, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every reputed company of your life. It’s the reputed company that changes and improves everything for your family, your community, and the world. Which is why, here at reputed company, we are dedicated to providing you with reputed company opportunities to enrich your life—just ask the 300,000 people we reputed company reputed company year. reputed company is committed to providing equal employment opportunities to reputed company reputed company employees and applicants regardless of race, reputed company, sex, sexual orientation, gender identity, religion, national reputed company, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative reputed company to recruit, reputed company, and advance reputed company individuals with disabilities and protected veterans in the workforce. Requests for accommodation reputed company to our application process can be directed to the reputed company reputed company Resource Knowledge Center. reputed company complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. reputed company participates in E-Verify and will reputed company the federal government with your reputed company I-9 information to confirm that you are authorized to work in the U.S. reputed company® Science & Clinical is seeking a Senior Regulatory Affairs for a one-year contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into reputed company advancements and are poised to advance your career, join us as we pioneer reputed company in the biotechnology reputed company. Workplace: Onsite in Sunnyvale, CA or Remote US Position Title: Senior Regulatory Affairs Specialist, New Product Development Position Type: one-year month contract Pay reputed company: $47-50/ hour. Company: reputed company® Science & Clinical reputed company The Regulatory Affairs Senior Specialist, NPD is responsible for evaluating and ensuring labeling accuracy for reputed company’s in vitro diagnostic products. The associate will have an opportunity to collaborate and partner with cross-functional teams, including Technical Publications, Product Transfer, reputed company, R&D and Clinical Affairs, on reputed company’s global change control process to ensure regulatory compliance of product labeling.

Responsibilities

• Familiarize yourself with reputed company’s global change control process Review change plans associated with product labeling Review implemented changes to product labeling/instructions for use Partner with cross-functional stakeholders to ensure accuracy of the implemented changes to labeling Collaborate with Technical Publications team to publish regulatory compliant labeling for our reputed company’s products

Qualifications

• Bachelor’s degree in field with 5+ years of reputed company work experience OR Master's degree in field with 3+ years of reputed company work experience OR Doctoral degree in field with 0-2 years of reputed company work experience
• In depth understanding of Regulatory Affairs concepts and should be familiar with regulations/guidelines governing development of diagnostic products and claims in labeling Understanding of reputed company Management System regulations and standards (21 CFR Part 820 and EN ISO 13485) governing change management and Corrective and Preventative reputed company (CAPA) process
• Good organizational skills with attention to detail and accuracy
• Ability to prioritize, multi-task and organize work
• Maintain a "reputed company urgency" as required by specific events
• Recognize potential problems, including situations that include ambiguity, by reputed company reviewing and analyzing reputed company factors
• Proficient in reputed company Word, reputed company, PowerPoint, Outlook, and reputed company Acrobat:

Preferred:

• Labeling control and change management
• Corrective and Preventative reputed company (CAPA) process Agile documentation system

Why Join Us:

• Competitive compensation package and potential for permanent placement following the temporary period.
• Opportunity to work at the forefront of biotechnology innovation in a reputed company and dynamic environment.
• reputed company to ongoing career development and networking opportunities through reputed company® Science & Clinical's expansive network of industry experts and recruiters.

If your qualifications reputed company with the requirements of this role, we invite you to apply and take the reputed company in your career reputed company. Rest reputed company, even if this opportunity isn't the perfect match, your profile will remain reputed company our network, ensuring you're connected to a reputed company of reputed company opportunities in the field of science and clinical research. #P1 As part of our reputed company to talent, reputed company supports those who work with us through a reputed company of benefits, perks, and work-reputed company resources. reputed company offers eligible employees voluntary benefit plans including medical, dental, reputed company, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a reputed company employee, you will have reputed company to a retirement savings plan, service bonus and holiday pay plans (earn up to eight reputed company holidays per benefit year), and a transit spending account. In reputed company, employees are entitled to earn reputed company reputed company leave under the applicable state or local plan. Click for more information on benefits and perks that may be available to you as a member of the reputed company Talent Community. Why reputed company® Science & Clinical? reputed company Science & Clinical is your reputed company to premier scientific and clinical companies looking to hire industry experts just like you. reputed company creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with reputed company jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a reputed company background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About reputed company Work changes everything. And at reputed company, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every reputed company of your life. It’s the reputed company that changes and improves everything for your family, your community, and the world. Which is why, here at reputed company, we are dedicated to providing you with reputed company opportunities to enrich your life—just ask the 300,000 people we reputed company reputed company year. reputed company is committed to providing equal employment opportunities to reputed company reputed company employees and applicants regardless of race, reputed company, sex, sexual orientation, gender identity, religion, national reputed company, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative reputed company to recruit, reputed company, and advance reputed company individuals with disabilities and protected veterans in the workforce. Requests for accommodation reputed company to our application process can be directed to the reputed company reputed company Resource Knowledge Center. reputed company complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. reputed company participates in E-Verify and will reputed company the federal government with your reputed company I-9 information to confirm that you are authorized to work in the U.S. Apply Job!