Regulatory Affairs Coordinator
Regulatory Affairs Coordinator
Posted on :
24-06-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Reasonable accommodation 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 FD.
- Supports monitoring and maintaining quality related information.
- This includes 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.
- Supervisory Responsibility.
- This position is responsible for managing the sales representatives in their territory.
- 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.
- 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.
- 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.
- 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.
- Bachelors degree(s) in engineering science or related area of study required.
- Clinical setting experience (intern and/or work) required.
- 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 Electromedicine Gmb.
- Must be detail-oriented and produce high quality work in a high-volume environment.
- Must be able to handle confidential information in an appropriate and professional manner.
- Problem Solving/Analysis.
- Detail Orientation.
- Customer Focus.
- Technical Capacity.
- Communication Proficiency.
- While performing the duties of this job prolonged periods of sitting at a desk and working at a computer are routinely required.
- 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.
Employment Type
Full Time
Key Skills
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