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Position Reports To: Manager RA
Position Directly supervises: No One
Job division: RA/QA
Over-Time Status: Non-Exempt
Purpose Of Position: To maintain and monitor a variety of cGMP documentation including complaint files, Medical Device Reporting (MDR), complaint processing system, investigations and closure, corrective action and preventive actions (CAPA), product investigations, complaint reportability assessment, and other related quality system records as required.
To fulfill this position successfully, an individual must be able to perform each essential function satisfactorily.
- Evaluates event(s) to determine if it qualifies as a complaint.
- Assesses complaint information provided; conducts additional investigations and escalates complaint to appropriate parties as needed.
- Compiles adverse event investigation information; summarizes investigation, production analysis, imaging review, instructions for use (IFU), and other relevant labeling and/or training materials; formulates conclusions.
- Manages customer relationship and expectations during course of complaint investigation and resolution process.
- Reviews potential reportable events to determine if regulatory filings are required.
- Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
- Maintains and completes complaint files for all customer complaints according to procedures.
- Maintains awareness of new products and government regulations and requirements.
- Documents and completes complaints in timely manner.
- Prepares and submits final customer correspondence as required.
- Reviews analysis reports; prepares summary reports.
- Performs other related duties and projects as business needs require at direction of management.
The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add, subtract, or change the job functions.
Minimum Qualifications: The requirements listed below are representative of the knowledge, skill, and ability necessary to successfully perform the essential functions of the position.
- Education and Experience:
- Bachelor’s degree in science, engineering, or equivalent relevant experience preferred.
- Minimum two (2) years of experience within regulatory affairs or medical documentation and reporting.
- Medical device experience preferred.
- Advanced understanding and interpretation of domestic and international complaint handling and reporting requirements required.
- Must possess proficient English skills, both written and verbal.
- Must possess effective oral communication and interpersonal skills with ability to deal with all levels of personnel in a professional and effective manner.
- Demonstrated written skills to convey high-level concepts in concise written form.
- Demonstrated consultative and relationship management skills.
- Demonstrated active listening skills.
- Ability to effectively present information and respond to questions from management and general stakeholders in initiatives.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to create and compose written materials with proper English grammar and punctuation.
- Ability to communicate clearly with employees, management, and team members.
- Ability to convey information in a clear and concise manner.
- Ability to provide constructive feedback in a professional and non-threatening manner.
- Ability to communicate effectively in a multi-cultural business environment.
Knowledge and Abilities:
- Proficient knowledge of general office procedures.
- Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
- Proficient knowledge of Good Documentation Practices (GDP) relating to complaint filing.
- Proficient knowledge of medical terms and human anatomy.
- Demonstrated knowledge of medical device reporting regulations and regulatory reporting regulations; experience in submitting e-MDR’s to the FDA.
- Demonstrated knowledge and understanding of policies, procedures, and guidelines relevant to quality compliance.
- Demonstrated problem-solving, critical thinking, and investigate skills.
- Demonstrated prioritization and time management skills.
- Demonstrated reliability, dependability, and flexibility in work habits.
- Demonstrated attention to detail and accuracy.
- Ability to prioritize and organize project tasks and goals effectively.
- Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
- Ability to read technical diagrams, graphs, and instructions.
Physical Demands: The physical demands listed below are representative of those that must be met by an employee to successfully perform the essential functions of this position.
§ Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.
§ Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.
§ Ability to frequently communicate with others.
§ Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.
§ Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.
§ Ability to seldom stand and/or walk for extended periods of time.
§ Ability to seldom climb stairs at some locations.
§ Ability to seldom push and/or pull up to five (5) pounds.
§ Ability to frequently lift or carry up to five (5) pounds.
§ Ability to keyboard for extended periods of time.
§ Ability to function in an environment with frequent interruptions.
§ Ability to deliver quality results under high pressure deadlines in a fast-paced environment.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position.
- Primarily an office setting environment with moderate noise levels and some direct exposure to hazardous physical substances.
- May frequently be exposed to a laboratory environment with moderate noise levels and moderate levels of dust, fumes, and mists.
- May have exposure to infectious diseases, blood, or other bodily fluids.