Document Control Records Management - Regulatory Affairs Specialist - Senior

Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Beckman Coulter regulatory programs. The incumbent's primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities. Responsibilities may include:

• Administration of the company's complaint management program for compliance to corporate requirements
• Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
• Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments. Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
• Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.

Educational requirements: Bachelor's degree in field with 5+ years exp. OR Master's degree in field with 3+ years exp. Medical Technologist background and IVD experience strongly desired.

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.