Regulatory Affairs Specialist I

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Job description

Overview:
The person in this position will provide support to the Regulatory or Clinical Affairs departments. This includes filing and maintenance of regulatory and clinical documents. Career Grid I

Responsibilities:
Maintain domestic regulatory affairs files.

Assemble, review, and submit regulatory documents to obtain and maintain marketing clearance for CBI products.

Assist in the collection, summarizing, interpretation, and publication of clinical evidence.

Maintain files and databases for clinical studies in which CBI acts as the study sponsor.

Proofread and type documents, letters and internal correspondence.

Mailing, faxing, copying, and filing documents.

Retrieve articles, textbooks or other publications from public databases.

Assist in assembling and writing Clinical Evidence Reports

(CER's)

Participate in external audits as required (FDA & TUV).

Assist Management with other corporate duties when required.

Remain current and apply the understanding of FDA-ISO 13485 and Quality System requirements in carrying out duties.

Remain current and apply the understanding of international regulations and standards, as well as Quality System requirements in carrying out duties.

Offer ideas on the department's strategic planning and organizing of international projects.

Perform data entry duties in various computer databases.

Participate in Cook working groups as requested by CBI management.

Assist Management with other corporate duties when required

Qualifications:
Bachelor's degree or equivalent. Life sciences, sciences, or engineering preferred.

Excellent written, verbal, and organizational skills.

Attention to detail.

Experience in using computers for word processing, databases, and spreadsheets.

Ability to handle multiple and changing priorities along with fluctuations in work load.

Experience in basic office equipment; i.e., fax, copier, computer, printers, phone systems, etc.

Able to present a professional and personable demeanor in phone, written, and face-to-face communications.

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Limited exposure to hazardous chemicals used in the manufacture of the product

• Physical demands are typical of an office and classroom environment