Regulatory Affairs Specialist - Fort Worth Tx

Advantage Technical is seeking a Regulatory Affairs Specialist for our client in Fort Worth, TX.

Provide regulatory support forour client's products that will be transitioning from the IVDD to IVDR CE Marking.Collaborate with cross-functional groups (e.g., Quality Assurance, Research& Development, Marketing) to collect and coordinate information andregulatory documentation to assemble IVDR compliant technical files. UpdateIVDR Labeling Conversion Log, assure all documentation is prepared andprocessed timely to meet the manufacturing schedule. Assist in the generationof Change Requests for product labeling according to Labeling conversion plan.Communicate and assist in the notification process to all InternationalRegional RAs. This may include sending the notification, logging regionalresponses and tracking RA Regional activities to completion. Ensureproduct restrictions are implemented, as required. Perform other IVDR orregulatory 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 You Bring:

• 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.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing – delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.