Director - Cardiovascular Regulatory Affairs

September 10

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MCRA

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

51 - 200 employees

Description

•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.

Requirements

•Bachelor’s degree in a scientific discipline (engineering, or a heavily technical writing-based curriculum preferred); Master of Science, Master of Science in Engineering, or PhD preferred. •Previous or current agency experience is required. •7+ years of regulatory affairs experience required. •4+ years of cardiovascular medical device experience required. The ideal candidate will have direct experience in one or more of the following device areas: •Cardiac Interventional Devices •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.