Associate Director - Cardiovascular Regulatory Affairs, Electrophysiology and Digital Health

March 29

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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 FDA experience 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 Diagnostics Devices, Cardiac Electrophysiology Devices, Implantable Electrophysiology Devices, Cardiovascular Digital Health Technologies • 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.)