Regulatory Affairs Specialist II
needed for a one year W2 contract for a Global Life Science company in Fort Worth, TX.
HYBRID
role. (3 days on sight)
Hourly Rate: $43-$45
The Regulatory Affairs Specialist
will provide regulatory support for the company's products that will be transitioning from the IVDD to IVDR CE Marking.
What You can your bring to the role:
- Education: Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
- Work Experience: 2 to 5 years' experience in Regulatory Affairs and/or experience in QA, R&D, Manufacturing within the IVD industry
- Effective communication skills, both written and oral
- Strong documentation and organizational skills
- Excellent computer applications skills including prior ERP experience and able to perform basic statistical analysis.
The day to day:
- Collaborate with cross-functional groups (e.g., Quality Assurance, Research & Development, Marketing) to collect and coordinate information and regulatory documentation to assemble IVDR compliant technical files.
- Update IVDR Labeling Conversion Log, assure all documentation is prepared and processed timely to meet the manufacturing schedule.
- Assist in the generation of Change Requests for product labeling according to Labeling conversion plan.
- Communicate and assist in the notification process to all International Regional RAs. This may include sending the notification, logging regional responses and tracking RA Regional activities to completion.
- Ensure product restrictions are implemented, as required.
- Perform other IVDR or regulatory related duties as required or assigned.
How You'll Make An Impact:
- Able to work with minimal supervision
- Strong customer orientation and focus
- Able to work independently and with others
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
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK.
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 https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
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.