Regulatory Affairs Manager Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2377314
Location: Round Lake, Illinois	Date Posted: 7/17/2008
Wage:	Category: Medical/Health
Job Code: 6559453

Job Description:
The incumbent will be responsible for global regulatory activities associated with new product development and on market support of disposable single use medical devices and custom intravenous and specialty products. Knowledge of software controlled medical devices, software accessories and interfaces, is a plus. - Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations; - Ensure that regulatory submissions and design documentation meet corporate and departmental standards with respect to technical excellence, resolving any controversies related to design and analysis; - Monitor applicable regulatory requirements; assure compliance with Baxter and external standards; - Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans; - Establish a leadership position on project development teams and ensure appropriate communication within RA and across other functional areas; - Develop and document sound regulatory decisions and justifications - Review of labels, labeling and promotional material for compliance with local and global regulations. - Lead and/or participate in RA and Corporate operational efficiency initiatives.QUALIFICATIONS:- Excellent verbal communication, presentation, and facilitation skills.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.pharmaceuticalcrossing.com