US-NJ: Branchburg-Senior Regulatory Affairs Associate
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Job Title: Senior Regulatory Affairs Associate
Job Location: NJ: Branchburg
Pay Rate: Open
Job Length: full time
Start Date: 2008-04-19
Company Name: LifeCell
Contact: HR
Phone: email only please
Fax: email only please
Description: Senior Regulatory Affairs Associate Mar 12, 2008 Branchburg, New Jersey Return to Search Results|Send job to a friend Description:
The SeniorRegulatoryAffairsAssociate will, under minimal supervision, coordinate, compile, and submit applications to FDA, the EU and otherregulatorybodies as required. Works with development teams and management to ensure rapid and timely approval of new devices and continued regulatory support of marketed devices includingreview of labeling and promotional materials. Keepabreast ofapplicableregulations,guidances, and standards.This position will report to the Director ofRegulatoryAffairs.
PRINCIPAL RESPONSIBILITIES: 1. Participates on project teams representingRegulatoryAffairs 2. Prepares or supports regulatory submissions (510(k)s Technical Files, Dossiers) in a timely manner meeting current regulations and guidance document requirements 3. Prepare regulatory strategies for medical devices and human tissue products to determine regulatory pathway to market including FDA "no 510(k)” rationales for devices 4. Reviews labeling to assure compliance with regulatory requirements for medical devices and human tissue products 5. Review promotional labeling to assure claims and indications are consistent with cleared / approved uses of device 6. Review promotional labeling for human tissue product to assure claims and indications are consistent with current product classification 7. Prepares outlines, summaries, status reports, memos, graphs, charts, tables and slides as necessary.
QUALIFICATIONS:
MINIMUM SKILLS AND EXPERIENCE: Experience in regulatory affairs and knowledge of FDA for the medical device industry and experience filing 510k(s).Must be able to learn and understand relevant technical and regulatory information and terminology for LifeCell products.
PREFERRED EDUCATION: Bachelors degreein a science- orengineering-related disciplineorRegulatoryAffairs.
PREFERRED SKILLS AND EXPERIENCE: 4 - 5years experience inan FDA-regulated industry with a minimum of 2 years of experience in regulatory affairs and full knowledge of FDA and ISO requirements for the medical device industry. Experience filing 510k(s). European Union experience with Class III devices is preferred. Previous PMA experience also plus. Experience with review of promotional labeling and advertising
TRAVEL REQUIREMENTS: Minimal
PHYSICAL REQUIREMENTS: Must be able to work in an office environment
WORKING ENVIRONMENT: Open office
COMMUNICATION SKILLS: Must be able to read, write and speak English
POSITIONS SUPERVISED:
CUSTOMERS: External – Global Regulatory Agencies Internal - Marketing, Development, Research, Quality, Operations and others who on occasion need regulatory advice
Please refer to Job code lifecell-483940 when responding to this ad.
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