Director, Regulatory Affairs - In Vitro Diagnostics

June 28

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MCRA

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

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Description

• MCRA is seeking an Director, IVD Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions for the firm’s IVD clientele. • The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. • The Director may also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.

Requirements

• Bachelor’s degree in a scientific discipline (biology, chemistry, biochemistry, genetics, or a heavily technical writing-based curriculum); Master of Science or PhD preferred. • 7+ years of professional experience in Regulatory Affairs related to development of medical devices/technologies. • 3-4+ years of direct IVD device regulatory affairs experience (reviewing and/or writing submissions) in one or more of the following product areas is required: microbiology devices (bacterial and/or viral identification and bacterial antimicrobial susceptibility), companion diagnostic (next generation sequencing-based CDx), flow cytometry, digital pathology, immunology or hematology). • FDA experience required. • Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. • Possesses engineering and/or biological background to assist with pre-clinical and clinical strategies and can effectively communicate these strategies to internal team members and clients. • Experience developing and/or reviewing regulatory submissions to the US FDA and/or experience with international regulatory affairs and the regulatory bodies governing them. • Knowledge and experience utilizing research and providing statistical analysis. • Strong research, analytical, critical-thinking, and problem-solving skills. • Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results. • Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry. • Strong professionalism with customer relations and managing client relationships. • PC/Technical skills: strongly proficient in MS Office Suite, Excel, Word, PowerPoint. • Excellent oral and written communication skills and presentation skills. • Ability to lead a team and mentor junior Regulatory Team members. • Experience working with C-Level and senior management.

Benefits

• Travel: 10% (to the Company’s offices and for meetings/conferences/etc.)