Job Information
Randstad US regulatory affairs specialist ii in fort worth, Texas
regulatory affairs specialist ii.
fort worth , texas (remote)
posted june 10, 2024
job details
summary
$50 - $53.57 per hour
contract
high school
category life, physical, and social science occupations
reference48290
job details
job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: Fort Worth, Texas
job type: Contract
salary: $50.00 - 53.57 per hour
work hours: 9 to 5
education: High School
responsibilities:
Perform regulatory assessments for US, EU, and Canada for changes on commercialized medical device product
Work with global regulatory affiliates to compile global regulatory impact for changes on commercialized medical device products
Create submissions for US FDA and Health Canada as well as compile and maintain STeDs for changes on commercialized medical device products
Coordinate and clearly communicate with team members to properly implement changes to medical devices
Remediate product labeling and STeDs for EU MDR compliance
Various other duties within the medical device regulatory lifecycle maintenance space
qualifications:
Need to have good experience assessing the impact from changes to devices - US and EU and CAN.
510K Experience
Must be extremely organized, have to be good at time management and multitasking.
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.