Description
This role is urgent, as the hiring manager is looking for someone to quickly join the team and be brought up to speed. The regulatory affairs senior specialist will come in and drive the submission process for the company's FDA and CE Mark submissions, including an IDE and a 510(K). The device will enable millions of people worldwide to receive treatment for their life-threating ailment from the comforts of their own home, rather than having to go to a dreary treatment facility. The ideal candidate will have exceptional writing skills, dedication, and a sharp eye for submissions procedures. The role can pay up to $140,000, as the ideal candidate can come in as a manager if s/he is exceptionally experienced.The following responsibilities will be at the center of the job:
- Drive the process and submission of an IDE and a 510(K)
- Communicate regularly with the FDA
- Serve as regulatory affairs lead for key product development teams
- Keep senior management informed in the regulatory process and strategies
- Write, compile and submit regulatory documentation to global health agencies for approval/clearance
We are looking for candidates who:
- Have exceptional writing skills and attention to detail
- Have played a major role in leading a 510(K) clearance or IDE submission
- Have a bachelors degree
- Have a minimum of 3-5 years of regulatory affairs experience in the medical device industry
- If the candidate is more experienced and has managed others, s/he may come in at the manager level
- Have a passion for revolutionary technology
- Will embrace the company culture, spirit, and commitment
To find out more about Real please visit www.realstaffing.com