NICO Corporation

NICO Corporation is a leader in modern interventional technologies used in a new way of performing less invasive brain surgery for subcortical and skull base lesions, including hemorrhagic stroke – the deadliest and most costly and debilitating kind of stroke. It is an outcomes-based company dedicated to revolutionizing minimally invasive neurosurgery through evidence-based, improved clinical and economic outcomes. More than 170 peer-reviewed independent papers, posters and abstracts have been published on improved clinical outcomes for appropriate patients and economic benefit to the healthcare institution using the technologies.

Nov 17, 2021  
Job Description: The primary focus of the Regulatory Affairs Specialist is to work closely with Quality and Engineering on the development, management and maintenance of regulatory-related registrations and processes for NICO’s products, and to participate and/or support in the development of new products. Responsibilities are, but not limited to the following: Preparing and/or managing the outsourcing of regulatory documentation for NICO’s products, including technical documentation, device licenses, 510k submissions, etc. Management of international registrations for NICO’s products (Canada, Australia, Europe, UK, Japan, etc.) Assessment of Regulatory requirements within new potential markets Writing and/or outsourcing the writing of Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 rev 4, and Post-Market Clinical Follow-Up Report in accordance with MEDDEV 2.12/2 rev 2. Developing, supporting and executing regulatory plans and strategies,...
NICO Corporation Remote (Indianapolis, IN, USA) Full time