Friday, March 14, 2008

Regulatory Affairs Managers & Associate Directors

Rapidly growing leader in the Medical Device Industry is looking to add talented professionals to their regulatory affairs team.

This is an exciting opporunity with temendous professional growth potential. If you are looking to advance your career in regulatory affairs and have experiance with class II medical devices, particularly if you work with any software driven / electromechanical products you will find this position very exciting.

Some of the responsibitities include:

Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;

Ensure that regulatory submissions for class II products, strong 510K submissions understanding

Monitor applicable regulatory requirements; assure compliance with company 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.

Job Requirements

Bachelor’s degree in engineering or scientific discipline, with a minimum of 3 years direct experience in US regulatory submissions for hardware/software medical device regulatory submissions.

Higher degree/PhD will be an advantage.

International regulatory experience/exposure preferable.

Experience in hardware/software medical device development, regulations, standards, and current industry practices.

This company is offering a highly compedative salary and benifits package. For more information about these great Regulatory Affairs Jobs please call Katie Corliss @ 207-510-6666 or visit our website at to submitt your resume for consideration.

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