Director, Regulatory Review Programs

Summary

Join a leading global non-profit organization as their Director of Regulatory Review Programs. You will oversee and manage the timely, compliant implementation of the FDA Third Party (3P510(k)) Review Program, including reviewing premarket Class II and III 510(k) IVD submissions. This role requires extensive experience in FDA review processes and device regulation, deep knowledge of FDA regulatory requirements, and expertise in managing teams and contractors. The Director will also serve as the Final Reviewer, ensuring the integrity of the review process. The position promotes a collaborative, professional remote work environment. This is a full-time position with a MCRA client.

Requirements

• Possess considerable knowledge and understanding of our client's and the use of our client's standards in the regulatory process
• Have extensive experience in the FDA review process and device regulation
• Possess deep knowledge and understanding of FDA regulatory requirements and interpretation of guidance
• Have extensive knowledge of clinical chemistry, device validation protocols, and the medical laboratory field in general
• Possess general knowledge of personnel and contractor management
• Have expertise in managing Office 365 platforms and collaborative information technology tools including setting organizational rules and protocols to ensure secure use and interaction
• Demonstrate skill in selecting and managing contractor relationships
• Possess skill in partnering with leadership colleagues to improve operational decision making through effective decision-support metrics
• Demonstrate strength in developing team members and creating a best-practice work culture
• Demonstrate proven flexibility, adaptability, and problem solving in a changing and dynamic environment
• Possess skill in communicating and building relationships
• Have exceptional verbal and written presentation skills
• Consistently demonstrate cultural awareness and sensitivity to global constituents; comfort interfacing with leaders in all parts of the world
• Demonstrate the ability to multi-task, meet deadlines and process information in support of changing program activities, as necessary
• Have proven ability to learn quickly, take initiative, and be accountable for results
• Be able to collaborate closely with a diverse team of individuals in a highly intense and fluid work environment
• Have a degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry/clinical chemistry, with additional coursework in mathematics through differential and integral calculus and/or advanced statistics
• Have a minimum of five years of experience in the regulatory review of device submissions, as well as specialized experience in the review of Class II and Class III IVDs with or without predicate device submission data

Responsibilities

• Plan and direct the review and evaluation of IVD 510(k) product submissions
• Identify actual or potential medical device problems and/or risks to public health
• Review scientific data in IVD submissions to ensure product safety and effectiveness
• Serve as an internal source of information and guidance on medical device-related issues applicable to IVDs, laws, regulations, and policies
• Plan, coordinate, and evaluate the program activities of the team
• Oversee and manage review staff (Product Specialists), contracted Technical Reviewers, and Third Party Review processes
• Allocate resources by assigning reviews to staff and contractors that possess the expertise required for the review component that is assigned
• Oversee budget and manage contract review fiscal processes
• Develop, maintain, and train a pool of contract Technical Reviewers
• Maintain a thorough knowledge and understanding of changing regulatory requirements for device review and clearance
• Act as Final Reviewer as defined by FDA for all 510(k) IVD product submissions
• Support efforts to develop client base for reviews
• Serve as a key team member in the promotion of the review process to user audiences
• Communicate and develop relationships with FDA programs related to IVD review and relevant international review programs
• Perform other duties and responsibilities as assigned by the supervisor
• Ensure an excellent and consistent member, volunteer, customer and user experience in all activities, services, and products for each constituency
• Ensure professionalism, ethics, and inclusiveness in all member, volunteer, and user activities
• Demonstrate unwavering commitment to collaboration through teamwork with staff, volunteers, stakeholders, and other partners
• Direct reports include Product Specialist(s), and the administrative Project Manager
• Support business development, marketing, communications, finance/accounting, and global strategy and operations