8 Regulatory Affairs Specialist II Jobs in Irvine, CA
Sorry! This job is no longer available. Please explore similar jobs listed on the left.
Yoh Services is Hiring a Regulatory Affairs Specialist II Near Irvine, CA
Category: Life Science
Employment Type: Contract
Reference: BH-372435
Regulatory Affairs Specialist II needed for a contract opportunity with Yoh Scientific's client located in Irvine, CA.
This position is for a molecular diagnostics manufacturer and the team is looking for candidates with a bachelor's degree along with 3-5 years of experience in RA, QA, R&D, Manufacturing or Project Management. IVD experience is a must.
Schedule: M-F, Hybrid, 3 days on-site. 8 am to 5 pm.
Responsibilities
- Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Company products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.
- Support the IVDR labeling conversion and revisions of technical files for all the Irvine products that are due to convert from the IVD Directive requirements to the new IVD Regulation.
- Work cross-functionally in weekly meetings to ensure the labeling conversion follows the plan.
- Monitor the monthly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional follow-ups, and product restrictions, as required.
- Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments.
- Requires a bachelor's degree in biochemistry, biology, medical technology or related fields
- 3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.
- Knowledge of FDA, and CE marking requirements for IVD products is a plus.
- Able to work independently and with others.
- Communication skills, including negotiation and persuasion.
- Analytical, problem solving, computer, and critical thinking skills.
- Thorough knowledge of policies, practices and procedures related to RA.
Contract: 12-month contract with possibility of extension or conversion.
Salary: $40 - $45 per hour depending on experience, W2
Recruiter: Ery Baniqued
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
Job Summary
Full Time
$81k-106k (estimate)
04/18/2024
04/21/2024
yohit.com
Philadelphia, PA
<25
Related Companies
The job skills required for Regulatory Affairs Specialist II include Regulatory Affairs, Problem Solving, Project Management, Communication Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Specialist II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Specialist II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Specialist II positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist II, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist II. You can explore the career advancement for a Regulatory Affairs Specialist II below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
