What are the responsibilities and job description for the Regulatory Affairs Coordinator position at Katalyst Healthcares & Life Sciences?
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 USA's 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 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 company's 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.
- Bachelor's 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 Electromatic in GmbH.
- 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.
