Director, Regulatory Affairs - In Vitro Diagnostics

MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
Position OverviewMCRA 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.

Position Responsibilities:

• Develop and execute regulatory services for client companies, including however not limited to:
• Regulatory Submissions (510(k), IDE, PMA, IND, BLA, & IND)
• Regulatory Strategy, Analysis & Development
• Design, Review & Implement Analytical and Clinical Testing
• Manage junior members of MCRA’s regulatory department.
• Assist in business development functions (i.e., provide insight on BD calls, bid defenses, etc.) to secure new clients and projects.
• Work directly with client companies and/or FDA without Director or other leadership oversight.
• Provide project leadership while maintaining sole relationship with client companies.
• Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance.
• Work with other regulatory leadership to help guide the progress and development of the spine team and the regulatory department.
• Technical writing and review of documents and deliverables.
• Represent MCRA at conferences and meetings as needed.
• Complete other duties and projects as assigned.
• Ensure all work products comply fully with standards, policies, and mission of MCRA.

Required Qualifications:

• 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.

Special Requirements:

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

NOTE: This job description is not intended to