MCRA is hiring a
Associate Director, Cardiovascular Regulatory Affairs in Worldwide

Summary

MCRA is seeking an Associate Director/Director for its cardiac electrophysiology clientele to manage regulatory strategy and submissions. The role requires a scientific degree, FDA experience, 7+ years of regulatory affairs experience, 4+ years of cardiovascular medical device experience, strong technical skills, and the ability to work in a multi-disciplinary team.

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
• 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
• Ability 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

Responsibilities

• Develop and execute regulatory services for client companies, including but 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 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

Preferred Qualifications

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