Regulatory Affairs Specialist 8/20/2016

FPC of Valdosta Naples, FL

Company
FPC of Valdosta
Job Classification
Full Time
Company Ref #
28889556
AJE Ref #
575946291
Location
Naples, FL
Job Type
Regular

JOB DESCRIPTION

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POSITION TITLE: REGULATORY AFFAIRS SPECIALIST
LOCATION: SOUTHWEST FLORIDA
RELOCATION ASSISTANCE: YES
_US CITIZEN AND PERM.RES. CANDIDATES ONLY - NO H1B TRANSFERS OR SPONSORSHIPS_

POSITION SUMMARY - A Medical Device industry leader in their product arena is seeking to hire a REGULATORY AFFAIRS SPECIALIST. This company has been named multiple times as one of Florida's Top 100 Best Companies to Work For.

GENERAL RESPONSIBILITIES - REGULATORY AFFAIRS SPECIALIST:

* Prepares and submits regulatory applications to secure worldwide product approvals with the FDA, Notified Bodies, Canada, and other International Countries. (510(k), IDE, PMA, CE dossiers, supplements, responses, state licensure / certifications, export certifications, product registrations, etc.)
* Develops regulatory strategies in accordance with corporate objectives.
* Serves as regulatory representative on cross functional product development teams.
* Evaluates and approves advertising and promotional materials including labeling, marketing literature, and protocols for regulatory compliance.
* Participates in qualitysystems audits as required.
* Gathers information from other departments and external resources as required for the preparation and submission of Regulatory applications.
* Uses regulatory references and internet searches- CFR, ICH, ISO, FDA.

EDUCATION AND EXPERIENCE - REGULATORY AFFAIRS SPECIALIST:

* Bachelors degree is required, plus five years direct medical device industry experience in regulatory affairs
* International, specifically EU RA experience preferred.

QUALIFICATIONS - REGULATORY AFFAIRS SPECIALIST:

* Working knowledge of regulatory requirements in Latin American countries
* Ability to work in fast paced environment and handle multiple tasks and requests.
* Comprehension of Orthopedic medical device technical/engineering terminology, OR ability to reference literature for understanding.
* Proficient software skills: Word/ Excel/ Power Point/database /bibliography programs.
* PC, database, research tools, internet research tools.

_Keywords: Regulatory Affairs Specialist, medical device, 510(k), regulatory submissions, premarket, PMA, IDE, CE mark, CE dossiers, product registrations, International, EU, Latin America, Orthopedic, FDA, international product registration, international submission, ISO, notified bodies, product approvals, regulatory compliance, quality system audit, labeling, advertising, promotion, marketing_