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Director, Regulatory Review Programs

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

United States

Offer summary

Qualifications:

Degree in physical or life sciences., Minimum 5 years in regulatory review., Experience with Class II and III IVDs., Extensive knowledge of FDA regulations..

Key responsabilities:

Oversee implementation of FDA 3P510(k) program.
Review submissions, resolve deficiencies, ensure safety.

MCRA SME https://www.mcra.com/

51 - 200 Employees

See more MCRA offers

Job description

Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly on MCRA's team, but rather for a fulltime position with a MCRA client that our team is helping to recruit and fill.

Our client is a leading global non-profit organization with a strong professional membership and active volunteers. Our client is seeking a Director of Regulatory Review Programs who is responsible for overseeing and managing the timely, compliant implementation of the FDA Third Party (3P510(k)) Review Program.

This includes reviewing premarket Class II and III 510(k) IVD submissions, determining eligibility, resolving deficiencies, and submitting the finalized 510(k) package and SE decision to the FDA. The Director also serves as the Final Reviewer, ensuring independent assessment and integrity in the review process. Additionally, the role promotes a collaborative, professional remote work environment aligned with the organization's values and commitment to diversity.

Key Responsibilities:

Review Program Implementation

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.

Review Programs Oversight and Management

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.

Key and Supporting Responsibilities:

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.

Primary Relationship Manager for:

FDA Centers for Devices and Radiological Health (CDRH) device review programs

Additional regulatory agencies as the Third Party Review Program expands

Image/Brand Responsibilities: 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.

People Management Responsibilities: Direct reports include Product Specialist(s), and the administrative Project Manager. Supports business development, marketing, communications, finance/accounting, and global strategy and operations.

Required Skills:

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.

Education and Experience:

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.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.