Description:
Assures all government and international report systems and documentation comply with regulatory requirements for medical device products in the US.
RESPONSIBILITIES:
Define and establish the consolidated US Quality Systems consistent with Regulatory Agency requirements.
Serve as the US focal point of contact with the US and Canadian regulatory agencies. Serve as the primary contact for FDA inspections.
Direct Regulatory Affairs performance across all US sites by ensure effective regulatory submissions, complaint handling, medical device reporting and other vigilance reporting, device registration and listing, field action reporting, labeling review and approval and clinical study oversight and management.
Monitor external regulation development by actively participating in different groups of the US regulatory community. Manage the communication of external regulations to all US sites and Global Regulatory Affairs.
Provide training to employees at all US sites on external regulations and RA policies and procedures.
Serve as Lead Auditor to support US and Global audit program.
Manage US RA function and personnel at all sites to include performance management, training, development, budget and special projects.
Advises corporate personnel regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.
Develops, implements, and reviews current policies and practices issued by Federal and international regulatory agencies.
Implements the requirements of ISO 9001, ISO 13485, 21CFR, cMDR throughout the US Organization as related to the Central Regulatory function.
QUALIFICATIONS:
Bachelor's Degree in a scientific discipline, life sciences, biomedical or other engineering science. Prefer a Master's or a PhD.
Minimum of 10 years experience in medical device regulatory with at least five years in a management role.
Previous experience in risk management processes; auditor qualification a plus.
Demonstrated success in developing a proactive organization in regulatory compliant environment.
Knowledge of current US and International regulations and guidelines; ability to develop, implement and mange an integrated regulatory compliant QMS; ability to lead multi-level and multi-discipline work teams to develop, implement and manage processes/business systems; effective verbal, written and presentation skills; strong influencing skills to lead the decision-making process with executive management, peers and subordinates.
Creative Placement Services
603-882-0700 (P)
603-882-0771 (F)
|
|