Director - Regulatory Review Programs

November 15

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MCRA

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Clinical Affairs • Quality Assurance • Regulatory Affairs • Reimbursement • Healthcare Compliance

51 - 200 employees

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.

Requirements

• Considerable knowledge and understanding 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.