R.A. Wylan & Co. Inc.,
Career Center

Remote -- Director of Regulatory -- Part-time

Location: Any US City
Job Type: Direct Hire
Salary: $1.00 - $2.00
Degree: Bachelor of Science; Master of Science; Doctor of Philosophy;
Date: 2/14/2018
Job ID: 02570196
Job Description
Director of Regulatory  

The ideal candidate will take on the following tasks:
·        Contribute to the strategic planning of the company’s regulatory affairs
·        Lead the implementation of the company’s regulatory strategy and provide evidence-based opinions and advice 
·        Manage all relations with FDA and 510k submission
·        Provide management with continuous input on regulatory matters and their interactions with business development, clinical development, commercialization, financial planning, manufacturing, and execution.
·        Manage day–to–day activities of regulatory consultants

The ideal candidate will possess the following qualities:
·        Experience developing at least 2  Class II medical devices from prototype-phase, pre-FDA approval to post-FDA approval commercialization 
·        Strong project planning and management skills, coupled with strong leadership skills and ability to drive results
·        Strong networking skills with solid record of maintaining and developing successful relationships with opinion leaders and investigators 
·        Strong conceptual thinking and innovative skills and ability integrate input from diverse fields of research and development
·        Advanced scientific knowledge in the area of neurology, digital signal processing, data science, clinical relations, or experimental trial design a plus