Sr. Regulatory Affairs Specialist
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Regulatory Affairs Specialist for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Supports new product development for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Viewed as departmental resource.
Reports observations/ problems clearly and concisely and takes appropriate actions
Demonstrates developing of advanced technical leadership skills within the department
Possesses and applies a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
Demonstrates strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities
Demonstrates knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance
Plans, conducts and executes assignments, reviewing progress and evaluating results
Operates with appreciable latitude for independent action or decision, and reviews progress with management Tasks
Qualifications/Preferred Work Experience:
Previous experience in legal, technical or a regulated environment
4-6 years applicable experience
Extensive knowledge of the Quality System Regulations (21 CFR)
Extensive knowledge of the Medical Device Directives (MDD) and MEDDEV guidance
Extensive knowledge of other regulations related to Pre Market Clearance/Approval Education/Special Training Required:
B.A. Or B.S.In Science, Legal, Regulatory or Engineering, or equivalent
RAC certification or applicable professional certification (preferred)