Associate, Regulatory Affairs (Spine Devices)

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.

 

The Associate, Regulatory Affairs will be a critical team member supporting US and international regulatory strategy and submissions for the firm's clientele. The primary roles and responsibilities include writing and reviewing regulatory submissions, development of overall regulatory strategy with senior MCRA staff, and communicating with regulatory bodies and clients with support of senior MCRA staff. The majority of projects will initially be for companies in orthopedics, cardiovascular, and other growing therapeutic concentrations of MCRA.

Responsibilities:

• Develop and execute regulatory services for client companies, including however not limited to:
• Regulatory Submissions (510(k), IDE, PMA, IND, BLA, & IND)
• International Regulatory Submissions (Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs))
• Regulatory Strategy, Analysis & Development
• Design, Review & Implement Pre-Clinical Testing
• Communicate with regulatory bodies and clients with support of senior MCRA staff.
• Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance.
• Work with other department heads and the general manager to guide progress and development of the regulatory department and company.
• 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.
• 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.

Special Requirements:

• Travel: 10% to the company's offices and for meetings and conferences
• DC-based

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.