Regulatory Affairs Manager

Location:
Ft. Lauderdale, FL

Description:
Will develop and execute strategies for governmental approval to introduce MAKO products to the global market, provide expert knowledge and advice on regulatory requirements, prepare regulatory submissions and negotiate approval with various governing bodies, and support all post-market activities.

Responsibilities:

• Company manager / resource on regulations for US, EU, Asian, and other international markets
• Work with existing consultant base as required to support MAKO regulatory objectives
• Implement necessary tools and manage company regulatory compliance areas on a day to day basis such as (but not limited to) CAPAs, complaint handling, MDRs, corrections and removals, compliance with general controls / special controls of the FD&C Act, EU vigilance
• Position will also be responsible for the creation, preparation, and achievement of regulatory submissions and approvals to introduce new products in the US, EU, Asia, and other markets
• Provide on-going regulatory management to product development teams for regulatory issues and questions
• In support with the director RA/QA/CA, act as company representative, developing and maintaining positive relationship with regulatory agencies
• Planning, coordination and preparation of internal ''Letters to File'' for product changes
• Manage foreign registrations and 'Permission to Export documents
• Review labeling, web page content, advertisements, and other marketing related content for regulatory claims
• Maintain annual facility registration, device-listing documents
• Support and perform internal quality audits as required
• Support and perform training as required
• Support management representative during management review meetings with meaningful metrics related to regulatory affairs
• Manage regulatory staff including a regulatory affairs specialist and build out staff as required.

• BS in a science or engineering
• Minimum of 5 years medical device (Class II, III) experience required
• Experience in dealing with domestic and international regulatory agencies
• Must be able to analyze and resolve non-routine product issues using sound independent regulatory judgment
• Must be able to routinely make regulatory decisions which affect immediate operations and may have a company-wide effectMust be thoroughly familiar with orthopedic devices and procedures and have actively participated and managed medical device regulatory submissions for Class II and Class III products
• Must have experience in working with complex medical devices such as medical electrical equipment with software e.g., image guided surgery, medical robotics a plus
• Analytical with a demonstrated problem-solving orientation, a self-starter
• Excellent communication skills and effective interaction with top management
• Computer proficiency in MS Word, Excel, Project, Visio, Power Point, and Excel.