Regulatory Affairs Coordinator
Regulatory Affairs Coordinator
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Essential Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Creates revises and implements quality standards as well as procedures i.e. Standard Operating Procedures (SOPs) etc. for Erbe USAs Quality Management System as an initial importer and distributor of medical devices in the United States. This includes updating all Systems to new/revised requirements by FDA.
Supports monitoring and maintaining quality related information. This includes Engineering Change Requests/Reports (ECRs) Controlled Documents Master Document List etc. (through to in servicing activities).
Assist in establishing and maintaining a system to electronically control quality related documentation including SOPs Standard etc.
Supports the training of Erbe personnel and agents.
Reviews as applicable and as necessary product specifications (e.g. dimensional aspects functions/features packaging labeling etc. and product testing (e.g. biological testing performance testing etc. involved with products to be distributed and in distribution by Erbe USA.
Assist in FDA Regulatory Submissions e.g. 510(k)s etc. to meet regulatory requirements and laws. Provides input to addresses Request for additional information by FDA.
Helps as needed with FDA Regulatory Filings e.g. Medical Device Reports (MDRs) to meet regulatory requirements and laws.
Assists in performing internal and external audits as well as supports the management of audits of Erbe USA from external personnel/organization.
Required Education and Experience
Bachelors degree(s) in engineering science or related area of study required.
Clinical setting experience (intern and/or work) required.
Position Requirements
Excellent verbal and written communications required; strong facilitation and interpersonal skills required.
Demonstrated computer skills to successfully use MS Office Outlook etc. and electronic quality systems from Erbe Elektromedizin GmbH.
Must be detailoriented and produce high quality work in a highvolume environment.
Must be able to handle confidential information in an appropriate and professional manner.
Competencies
Problem Solving/Analysis.
Results Driven.
Detail Orientation.
Customer Focus.
Technical Capacity.
Communication Proficiency.
Supervisory Responsibility
This position is responsible for managing the sales representatives in their territory.
Work Environment
This position operates in a professional office environment and routinely uses office and computer equipment typical of similar positions. The position is also exposed to all manner of products in the companys portfolio.
Physical Demands
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. While performing the duties of this job prolonged periods of sitting at a desk and working at a computer are routinely required. The employee frequently is required to lift and/or carry up to 20 pounds. Please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.
Position Type and Expected Hours of Work
This is a fulltime position. Days and hours of work are typically Monday through Friday with substantial variety in start and finish times. Occasional evening and weekend work may be required as job duties demand.
Travel
This position requires no measurable travel.
Additional Eligibility Qualifications
None required for this position.
Work Authorization/Security Clearance
Employees must be legally authorized to work in the United States. Employees must not be specifically barred from working with Federal contracts government entities or otherwise listed on excluded parties list as maintained by the Federal government.
AAP/EEO Statement
Erbe employees and applicants for employment are protected by federal laws Presidential Executive Orders and state and local laws designed to protect employees and job applicants from discrimination on the bases of race religion color sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability family medical history or genetic information political affiliation military service or other nonmeritbased factors. These protections extend to all management practices and decisions including recruitment and hiring practices appraisal systems promotions and training and career development programs.
Other Duties
Please note this position description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice.
AtWill Employment
This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employmentatwill rights at any time.
Required Experience:
IC
Employment Type
Full-Time
