Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
This 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.
Support UDI and GUDID database operations
Responsible for FDA requests to ensure customs/trade compliance
Assist with the preparation and submission of FOAIs, FDA 513g requests, Certificates to Foreign Government and Pre-Submission applications.
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
Supervisory Responsibilities: This job has no supervisory responsibilities.
Bachelor's Degree (BA/BS) from four-year college/university.
3-5 years regulatory experience.
510k submissions experience.
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
Sybron Dental Specialities Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Internal Number: KAV002108
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.
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.5B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands... allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.