Neurology Regulatory Affairs
The Neurology Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm’s neurology 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 staff. Most projects will initially be based around the following product types: invasive and non-invasive central and peripheral nervous system stimulation devices (electrical, magnetic, ultrasound, or other) for neurological and/or psychiatric intended uses, and we expect for this position to develop into supporting additional technological areas (e.g., neurovascular and neurodiagnostic devices) and other growing therapeutic concentrations of the company.
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 staff.
- Work collaboratively with other departments, including clinical, reimbursement, and quality assurance.
- Complete other projects and responsibilities as assigned.
- S. or B.A. in a scientific or related discipline (biology, engineering, or a heavily technical writing-based curriculum) required. Advanced degree preferred.
- Minimum of 3+ years of direct experience in regulatory affairs related to medical devices, drugs and/or biologics, which includes experience assisting in the writing and/or reviewing of regulatory submissions.
- An understanding of engineering and a biological science 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 is required.
- International regulatory experience including developing Technical Files, Design Dossiers, and Clinical Evaluation Reports (CERs) is preferred.
- 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 preferred.
- Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
- 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.