Job Description

Job Description

Job Description

Description:

Assist the Regulatory Affairs department with processing documentation for products requiring governmental application and fillings.

Essential Job Functions:

Responsibility for assisting the DRA in the preparation of regulatory submissions for marketing of new or modified medical devices in the United States (Food and Drug Administration) and Canada (Health Canada). This position will assist in reviewing, printing, binding, filing submission files and preparing policies and procedures as directed by the DRA.

· Assist in preparing FDA documentation for filing.

· Assist in preparing meeting presentations and presenting meeting presentations.

· Assisting with preparation of department policies and procedures.

· Ensure Regulatory Affairs files are accurately maintained and in compliance.

· Support the Director of Regulatory Affairs or similar position.

· Communicate and collaborate with RA members at Asahi Intecc Japan.

Core Competencies:

· Cooperativeness

· Problem solving/analysis

· Attention to detail

· Oral and written communication proficiency

· Active thinker and actor

· Self-management

Minimum Qualifications:

· A minimum of 2 years of related experience is required.

· Knowledgeable in FDA regulations to medical devices required.

· Effective verbal and written communication skills a must.

· Strong interpersonal skills required.

· Proficient in Word, Excel, and PowerPoint required.

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