Regulatory Affairs - North Americas

Naples, FL 34108

Posted: 01/11/2019 Industry: Biotech Job Number: 231069 Pay Rate: 70000 - 110000
Essential Duties and Responsibilities:

With minimal supervision, prepares and writes 510(k) submissions and Letters-To-File
Act as the regulatory representative on product development teams for new and modified devices
Develops regulatory strategy for new and modified devices for U.S.
Reviews device changes to assess regulatory impact
Gathers information and data from other departments and external resources for regulatory submissions in both U.S. And Canada
Reviews and approves advertising and promotional materials
Participates in regulatory or quality systems audits as required


Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.



Education and Experience:

Bachelors degree required, masters degree preferred.

5+ years experience in writing 510(k) submissions and Letters To File required.

Strong interpersonal, oral and written communication skills required.



Knowledge and Skill Requirements/Specialized Courses and/or Training:

Effective interpersonal and communication skills
Proficient in Microsoft Office
Ability to work in fast paced environment
Strong written communication skills
Ability to independently manage multiple projects over extended periods of time
Internal and external communication and collaboration skills
Comprehensive understanding of orthopedic technical/ engineering/medical terminology
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