Provides quality and timely support to obtain marketing clearance/approval for new products; devices/drugs, drug-device combinations. Maintains marketability of existing products.

Providing assistance in supporting the process of meeting requirements established by US FDA and international governmental agencies in introducing vascular medical devices to market.
* Planning and preparing PMA and 510K FDA submissions.
* Reviewing Change Orders and assessing the regulatory impact of product changes on US, European, and International regulatory strategies.
* Supporting post-market regulatory compliance activities for US FDA and International


Requirements:

Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines and four years of related experience. International Regulatory Affairs experience preferred. Must have completed three (3) 510 (k) submissions and demonstrated ability to prepare submissions independently.

• Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and ISO 13485 Quality System Standards.
• Self-motivated, self-directing, strong attention to detail and excellent time management skills.
• Strong interpersonal skills and the ability to communicate well verbally and in writing with others.

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