Manager, Regulatory Affairs at Erbe USA, Incorporated in Marietta, Georgia

Job Description:

Federal Applicant Rights - English

Federal Applicant Rights - Spanish

Essential Responsibilities

• Creates, revises, and implements quality standards as well as procedures (i.e., Standard Operating Procedures (SOPs), etc.) for Erbe USA's Quality Management Systems as an initial importer and distributor of medical devices in the United States. This includes updating all Systems to new/revised requirements by FDA.


• Back up to the Sr. Director of Quality & Regulatory Affairs as the quality representative for Erbe USA. Informs Erbe USA executives and other involved personnel on all quality related matters (including presenting/moderating Management Reviews).


• 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.


• Authors, revises, and/or reviews FDA Regulatory Submissions (e.g., 510(k)s, etc.) to meet regulatory requirements and laws. Addresses Request for additional information by FDA.


• In conjunction with the Sr. Director of Quality & Regulatory Affairs, evaluates and establishes controls for all suppliers/vendors who have an impact on product quality; conducts initial assessments as well as yearly performance reviews to convey and resolve quality issues as they arise.


• Provides regulatory training to Erbe personnel and agents.


• Assist in establishing and maintaining a system to control quality related documentation including SOPs, Standard Testing Procedures (STPs), Marketing Materials, etc.


• 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).


• Performs regulatory work regarding nonconformances, complaints (including Medical Reporting (MDR) assessments and filing MDRs).


• Assists in performing internal and external audits as well as supports the management of audits of Erbe USA from external personnel/organization.


• In conjunction with the Sr. Director of Quality & Regulatory Affairs, ensures compliance to regulatory requirements involved with any potential recall or recall.    

 

Supervisory Responsibility

This position, at this time, is an individual contributor and has no direct supervisory responsibility.

 

Work Environment

This position operates in a professional office environment and routinely uses office and computer equipment typical of similar positions.

 

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.

 

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. Occasional evening and weekend work may be required as job duties demand.

Travel

This position requires occasional travel with some international travel included.

Required Education and Experience

• Bachelor’s degree(s) in engineering, science, or related area of study required.


• 10+ years’ experience in the medical industry experience in quality control, quality assurance and regulatory affairs required.


• Competence in applying and assuring compliance to Quality System Regulation (QSR) and ISO 13485 requirements per FDA and EU MDR requirements as directed by Erbe Elektromedizin GmbH, etc. (including interfacing with involved regulatory agencies such as FDA).

Position Requirements

• Excellent verbal and written communications required; strong facilitation and interpersonal skills required.


• Thorough understanding of research, development, design, validations, quality activities, and regulatory necessities involving medical devices are necessary with operations and quality systems auditing capabilities.


• Must be able to communicate complex information to all levels within the organization.


• Demonstrated computer skills to successfully use MS Office, Outlook, etc. and electronic quality systems from Erbe Elektromedizin 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.

Competencies

• Problem Solving/Analysis.


• Results Driven.


• Detail Orientation.


• Customer Focus.


• Technical Capacity.


• Communication Proficiency.

 

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 non-merit-based 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 job 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.

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time.  The company may exercise its employment-at-will rights at any time.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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