Medical Device, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
This Regulatory Affairs Specialist position is responsible for assisting in the preparation and submission of domestic and/or global product registrations. The candidate must have a basic working knowledge of domestic and/or international medical device regulations, including 510k and international registration dossier submissions.
Essential Duties and Responsibilities:
Responsible for assisting in the preparation and compilation of domestic and international product registration submissions, with guidance. This includes, but is not limited to, 510ks, international dossiers and CE technical files.
Responsible for agency establishment registrations and device/drug listings.
Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, Health Canada and Notified Body.
Support domestic and international field corrective actions and adverse event reporting.
Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management.
Perform special projects as needed.
Scope: Domestic and International
Bachelor's Degree (BA/BS)
2+ years of work experience in regulatory experience in medical devices (or any regulated industry) with domestic and international submission experience preferred .
Excellent written and oral communication skills.
Strong analytical and organizational skills; ability for detail and precision.
Team player with ability to work independently.
Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Must have the ability to work in a team-oriented environment and is able to meet tight deadlines. Building internal working relationships with all department levels. In the discretion of RA management, handles routine interactions with FDA and other regulatory agencies.
Minimal experience in adverse event reporting and/or field corrective actions preferred.
Internal Number: 00000
About KaVo Kerr
KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.