Reg Affairs Manager - Medical Devices, Neuroscience

Understand and interpret US and global regulatory requirements for medical devices, in vitro diagnostics (IVD), and combination products.

Author pre-submissions, breakthrough device designation requests, study risk determination requests, and 513(g) Requests for Information.

Review nonclinical, analytical and clinical protocols including clinical investigations and performance evaluation plans and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.

Draft and prepare product technical documentation for submission briefing books and applications, design dossiers, technical files, Summary of Technical Documentation files.

Prepare IDE submissions to support investigational use and provide regulatory support for clinical studies ensuring compliance with Good Clinical Practice.

Review and / or author medical device marketing application submissions including 510(k), de Novo classification, PMA, HDE and lead process through clearance / approval.

Finalize and review regulatory documents and submissions.

Review product labels, labeling, and promotional materials.

Requirements :

Bachelors Degree or equivalent

Solid understanding of global regulatory requirements and regulatory affairs procedures for medical device, IVD, and combination product development, investigational use, and marketing authorization is required.

Experienced with therapeutic medical devices. Experience with neurology devices is a plus.

Proven experience in authoring FDA marketing applications, investigational use applications and pre-submission engagements is required.

Working knowledge of investigational device requirements including 21 CFR Part 812, ISO 14155, ISO 20916, and ICH is required.

Technical writing skills and proficiency at compiling successful submissions for the appropriate audience is required.

Detailed understanding of product requirements related to software verification and validation, cybersecurity, basic safety and performance for medical electrical equipment, biocompatibility (ISO 10993), risk assessment and usability.

Demonstrated project management and communication (written and oral) skills to all levels within the organization and external to the organization.

Excellent judgment, analytical, and decision-making to manage sophisticated projects in parallel and handle rapidly changing priorities.

Demonstrated ability to prioritize competing tasks and deadlines, and coordinate complex information.

Must be self-motivated by working independently and having the ability to take ownership of their responsibilities. Capable of delegating tasks and facilitating the completion of assignments.

Demonstrated analytical thinking to comprehend and analyze an issue, and resolve problem.

Join an organization that values integrity, intensity, innovation, and involvement. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.