Associate, Regulatory Affairs

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 Overview

The Associate, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm’s Neuro, Digital Health, and AI/Imaging clientele. The primary roles and responsibilities include writing and reviewing regulatory submissions, development of overall regulatory strategy and communicating with regulatory bodies and clients with support of senior MCRA staff.

Job 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 Pre-Clinical Testing
• Provide consultation on biological safety risk assessment, testing plans / strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO Standards, FDA Guidance, and global regulatory requirements
• Communicate with regulatory bodies and clients with support of senior MCRA staff
• Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance
• Complete other projects and responsibilities as assigned
  
  
  

Required Qualifications

• B.S. or B.A. in a scientific or related discipline (biology, engineering, or a heavily technical writing-based curriculum) required. Advanced degree preferred
• 1-3 years of experience in regulatory affairs related to medical devices, drugs and/or biologics, assisting in the writing and/or reviewing of regulatory submissions. Post-graduate education with strong research and technical writing curriculum may be substituted for experience
• Experience with Neuro, Digital Health, or AI/Imaging Devices is highly preferred
• An understanding of engineering and biological sciences to assist with pre-clinical and clinical strategies with the ability to effectively communicate these strategies to internal team members and clients.
• An understanding of clinical research and data analysis
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Strong research, analytical and problem-solving skills
• Knowledge of medical, anatomical, and physiological terminology
• Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently
• Strong written and verbal communication and presentation skills
• Strong intellectual curiosity and a desire to develop an in-depth understanding of systems, business processes and complex issues
• Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications
• Excellent oral and written communication skills
• Ability to read, analyze, and interpret complex documents
• Travel Up to 10%
  
  
  

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.