MCRA · 1 day ago
Director, Regulatory Review Programs
United States
Full-time
Remote
Director/Executive
5+ years exp
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Responsibilities
Plans and directs the review and evaluation of IVD 510(k) product submissions.
Identifies actual or potential medical device problems and/or risks to public health.
Reviews scientific data in IVD submissions to ensure product safety and effectiveness.
Serves as an internal source of information and guidance on medical device-related issues applicable to IVDs, laws, regulations, and policies; and Plans, coordinates, and evaluates the program activities of the team.
Oversees and manages review staff (Product Specialists), contracted Technical Reviewers, and Third Party Review processes.
Allocates resources by assigning reviews to staff and contractors that possess the expertise required for the review component that is assigned.
Oversees budget and manages contract review fiscal processes.
Develops, maintains, and trains a pool of contract Technical Reviewers.
Maintains a thorough knowledge and understanding of changing regulatory requirements for device review and clearance.
Acts as Final Reviewer as defined by FDA for all 510(k) IVD product submissions.
Supports efforts to develop client base for reviews.
Serves as a key team member in the promotion of the review process to user audiences.
Communicates and develops relationships with FDA programs related to IVD review and relevant international review programs.
Performs other duties and responsibilities as assigned by the supervisor.
Responsible for ensuring an excellent and consistent member, volunteer, customer and user experience in all activities, services, and products for each constituency.
Responsible for professionalism, ethics, and inclusiveness in all member, volunteer, and user activities.
Responsible for unwavering commitment to collaboration through teamwork with staff, volunteers, stakeholders, and other partners.
Direct reports include Product Specialist(s), and the administrative Project Manager.
Supports business development, marketing, communications, finance/accounting, and global strategy and operations.
Qualification
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Required
Considerable knowledge and understanding of our client's and the use of our client's standards in the regulatory process.
Extensive experience in the FDA review process and device regulation.
Deep knowledge and understanding of FDA regulatory requirements and interpretation of guidance.
Extensive knowledge of clinical chemistry, device validation protocols, and the medical laboratory field in general.
General knowledge of personnel and contractor management.
Expertise in managing Office 365 platforms and collaborative information technology tools including setting organizational rules and protocols to ensure secure use and interaction.
Demonstrated skill in selecting and managing contractor relationships.
Skill in partnering with leadership colleagues to improve operational decision making through effective decision-support metrics.
Strength in developing team members and creating a best-practice work culture.
Proven flexibility, adaptability, and problem solving in a changing and dynamic environment.
Skill in communicating and building relationships.
Exceptional verbal and written presentation skills.
Ability to consistently demonstrate cultural awareness and sensitivity to global constituents; comfort interfacing with leaders in all parts of the world.
Demonstrated ability to multi-task, meet deadlines and process information in support of changing program activities, as necessary.
Proven ability to learn quickly, take initiative, and be accountable for results.
Ability to collaborate closely with a diverse team of individuals in a highly intense and fluid work environment.
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.
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.
Company
MCRA
MCRA is a medical device, diagnostics, and biologics CRO consulting advisory firm.
51-200 employees
H1B Sponsorship
MCRA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Michael Anselmo
Vice President of Reimbursement, Health Economics and Market Access
D
David W. Lown
President
Recent News
2024-05-21
2024-05-05
Company data provided by crunchbase
