The Senior International Regulatory Affairs Specialist is responsible for execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position will manage necessary regulatory and project management activities required for product market entry and compliance, and ensures procedures comply with regulatory agency specifications. This individual will provide a sense of urgency to cross functional teams responsible for global programs and ensure effective communication with business partners worldwide.
Essential Job Functions:
Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code.
This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions.
Some travel, approximately 15%
The noise level in the work environment is usually quiet to moderate.
This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned, and activities may change at any time with or without notice.
Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination?based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.