Essential Functions: (The reason this job exists is to perform these functions. These functions are performed regularly, seriously impacts other jobs, and there are a limited number of employees whom performance of the function can be distributed).
Review and proofread documents, product labels, and new product questionnaires
Communicate with customers, suppliers, employees, and regulatory agencies to answer questions, address concerns, explain information, and resolve issues
Maintain updated systems for databases and filing of records
OTC registrations with the FDA
GUDID and UDI databases
FDA shipment holds/detention
Certificate to Foreign Government
ISO 13485 working knowledge and auditing experience a plus
Other Functions: (Incidental to the purpose or the job. These functions are performed infrequently and have little consequences to other jobs if not performed).
Performs other duties as required.
Essential Qualification:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the competencies (minimum knowledge, skill, and ability) required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
Required Knowledge: As a point of contact for regulatory agencies, customers, suppliers, and other departments, the regulatory assistant needs to make a good first impression with a professional demeanor and attitude.
Education/Certification: Bachelor’s Degree or related field or equivalent experience and instruction.
Experience Required: 1-2 years documentation experience in regulatory affairs.
Skill and Ability:
Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel)
Strong communication skills; ability to interact productively with supervisors and peers.
Time management skills
The ability to work with electronic documents
Familiar with FDA medical device and OTC databases, ISO 13485:2016/MDSAP
cGMP/QSR Part 820
Internal Number: RA001
About Dynarex Corp.
Founded in 1967, Dynarex serves the medical products and equipment industry. From its’ humble beginnings, Dynarex has grown into a well-known brand leader providing expert supplies at an exceptional value. Today, Dynarex offers thousands of SKU level products to meet the demands of almost every market segment. The full line includes disposable medical supplies and durable medical equipment to offer a truly unique one-stop shopping experience.