Description
Class III medical device company - Regulatory Affairs Project Manager - San Diego, CAThe position will report to the senior manager of U.S. regulatory affairs, and the regulatory team looks to expand from 8 members to 11 in the near future. The project manager salary can pay up to $120,000 with room for relocation assistance if necessary.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Participation in the development of regulatory strategies and prepare regulatory submissions
* US submissions include IDEs, 510(k)s and PMAs for new product lines and current products, as well as international market submissions when required
* Represent Regulatory Affairs on various cross-functional teams
QUALIFICATIONS
A Bachelors degree is required, as is at least 5 years work experience in a medical device company. Experience working on regulatory submissions with PMA products is essential as well. The project manager must have strong writing, editing and analytical skills and must have experience in developing complex submissions with minimal supervision. Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports. Must work well independently or within a cross-functional team environment.
To find out more about Real please visit www.realstaffing.com