Regulatory Affairs Manager Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2373845
Location: Round Lake, Illinois	Date Posted: 7/16/2008
Wage:	Category: Medical/Health
Job Code: 6511073

Job Description:
The incumbent will be responsible for global regulatory activities associated with new product development and on-market support of software controlled medical devices, software accessories and interfaces, and associated single use medical devices.- 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.

For more information, please click here to visit us at PharmaceuticalCrossing

For further information, please visit us online at http://www.pharmaceuticalcrossing.com

Sign Up Now

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