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Job Title: Dir - Medical Devices
Job Location: NJ: Clark
Pay Rate: Open
Job Length: full time
Start Date: 2008-09-11

Company Name: L'Oreal
Contact: Recruiter
Phone: email only please
Fax: email only please

Description: |My Career Center|View Job Cart| Dir - Medical Devices PRSM-005326 Other 375 - Corporate R & D Clark NJ FUNCTION: Responsible for compliance with all aspects of US medical device regulations, including both submissions and compliance activities. Liaison with international product development teams. Interact with various US marketing groups and the FDA on all medical device issues. II. PRINCIPAL ACCOUNTABILITIES --Develop regulatory strategies for US submissions - Plan and execute regulatory activities to obtain and maintain US regulatory approvals - Ensure compliance with relevant FDA and ISO regulations -Determine the need to file medical device regulatory documents, e.g., 510(k)s, IDEs, in the US - Prepare US submissions and work with FDA to obtain product approval/clearance -Maintain knowledge and keep company informed of US device regulatory requirements - Participate on International Product Development teams, providing regulatory strategy timelines and directions -Participate in copy approval for labeling and promotional materials for medical device, -Manages compliance with the MDR function (adverse event reporting), Performs specification change review associated with manufacture of the device for regulatory implications; -Assures appropriate device listing, establishment registration, etc. is being maintained. - -Provides input to clinical and preclinical medical device study plans - Contribute to the development of US regulatory internal trainings and programs REQUIREMENTS: III. DESIRABLE TRAINING AND EXPERIENCE: Masters degree with preference for advanced degree. Ten years minimum of hands-on medical device experience in industry. Must have been in a senior position in medical device FDA negotiations, copy approval and have device GMP related experience. 510(k)development and writing experience required. Knowledge of clinical and non-clinical testing requirements and procedures. Ability to function independently and interact well across research and marketing entities. Strong preference for experience with mechanical/electrical medical devices. French language fluency considered a plus. Incumbent should be willing to participate in other departmental activities on an as needed basis. Must be legally eligible to work in the US on an on-going basis.

LOreal USA is an equal opportunity employer M / F / D / V. With limited exception, candidates must be legally authorized to work without employer sponsorship, both currently and in the future. Add to Cart

Please refer to Job code lorealus-2209013 when responding to this ad.

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