The Regulatory Affairs Specialistposition 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
Supervisory Responsibilities: This job has no supervisory responsibilities.
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.
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 Company website 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.
Company and all Company Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: Company website.pdf.