Customer Service
Spectraforce
North Chicago, Illinois
a month ago
Job Description
Description:
Job Title: Customer Service
Duration: 06 months (potential extension)
Location: North Chicago, Illinois, 60085
Summary:
The Device Tracking Analyst will communicate with customers to obtain and/or verify device tracking information in compliance with device tracking regulations established by the FDA and international regulatory bodies. He/she will facilitate actions identified to improve customer experience and patient safety. He/she will participate and/or lead in the identification and implementation of device tracking management system improvements, including technical support, and updates to procedures and forms used in the device tracking process. Assist globalization of requirements, where necessary. The individual is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Works with little to no supervision.
KEY DUTIES AND RESPONSIBILITIES:
Process and maintain device tracking files in the device tracking system to support compliance with device tracking regulations and internal procedures. Ability to analyze information for device tracking requirements under 21 CFR 821 and SOR/98-282.
• Initiate device tracking files when forms are received in a timely manner. Maintain and update device tracking system. Record all activity in both hard copy (when applicable) and computer files.
• Maintain a knowledge and understanding of current Device Tracking regulations, Device Tracking guidelines, and Device Tracking interpretations.
Provide generalized company, departmental and device tracking knowledge as required.
• Coordinate with inter- and intra-departmental customers to ensure device tracking information and inquiries are communicated appropriately.
• Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing “talking points” and communicating corporate policy.
Support department processes and workflow
• Process outgoing faxes, incoming mail, perform data entry, filing and copying.
• Initiate and process follow up activities to gather information, submit notifications, etc.
• Inform internal and/or external customers of the device tracking requirements.
• Ability to monitor several files at once, including status and follow-up as necessary.
• Respond to verbal and written requests from internal and external customers. Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files, following complaint handling regulations 21 CFR 820.198, and SOR/98-282, and internal procedures.
• Ability to identify non-complaint customers and forward to management for resolution.
25%
Provide assistance with various departmental projects that may include:
• Write/revise department procedures as assigned.
• Assist in the coordination of department personnel regarding device tracking and/or complaint handling activities to ensure compliance with applicable regulations.
• Develop training content.
• Train new staff and conduct training/re-training on company policies, Device Tracking regulations, complaint handling regulations, and departmental practices.
• Support the department on special projects as needed.
• Assist in device tracking audit activities.
• Support regulatory inspections.
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job. Education and Experience
• AA degree, with three to five years previous experience in regulatory, quality, clinical, or related customer service setting; or equivalent combination of education and experience. Bachelor’s degree is strongly preferred.
ESSENTIAL SKILLS:
• Knowledge in device tracking policies and requirements. Ability to understand the impact of regulatory compliance requirements (e.g. 21 CFR 821, 21 CFR Part 11, SOR/98/282 and other regulations as they apply)
• Ability to function in a controlled environment by the FDA and other regulatory authorities.
• Ability to communicate effectively, both verbally and in writing.
• Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
• Knowledge of clinical, surgical techniques and procedures, and medical terminology.
• Ability to work effectively with a diverse network of internal and external departments and/or individuals.
• Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
• Skill in demonstrating a professional phone manner.
• Effective communication with physicians and nurses as required.
• Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
• Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
• Ability to take initiative and make decisions.
• Ability to demonstrate leadership in job performance by example.
* Ability to accurately perform detail-oriented work.
• Ability to be flexible in changing daily workload priorities as directed.
• Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
• Ability to coordinate and synchronize multiple projects.
• Ability to monitor and coordinate department workloads.
• Ability to develop and deliver training.
• Ability to manage a high-volume case load.
• Ability to think critically and analytically.
What are the top 3-5 skills, experience or education required for this position:
Critical thinking skills to problem solve or identify when to escalate
Ability/experience in working both independently and as a team
Experience in working in a controlled/regulated environment (e.g. federal/state regulations, privacy)
Experience in customer service, especially communicating sensitive information over phone in email with tough calls
Minimum associate’s degree; bachelor degree preferred
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $22.00/daily.
Job Title: Customer Service
Duration: 06 months (potential extension)
Location: North Chicago, Illinois, 60085
Summary:
The Device Tracking Analyst will communicate with customers to obtain and/or verify device tracking information in compliance with device tracking regulations established by the FDA and international regulatory bodies. He/she will facilitate actions identified to improve customer experience and patient safety. He/she will participate and/or lead in the identification and implementation of device tracking management system improvements, including technical support, and updates to procedures and forms used in the device tracking process. Assist globalization of requirements, where necessary. The individual is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Works with little to no supervision.
KEY DUTIES AND RESPONSIBILITIES:
Process and maintain device tracking files in the device tracking system to support compliance with device tracking regulations and internal procedures. Ability to analyze information for device tracking requirements under 21 CFR 821 and SOR/98-282.
• Initiate device tracking files when forms are received in a timely manner. Maintain and update device tracking system. Record all activity in both hard copy (when applicable) and computer files.
• Maintain a knowledge and understanding of current Device Tracking regulations, Device Tracking guidelines, and Device Tracking interpretations.
Provide generalized company, departmental and device tracking knowledge as required.
• Coordinate with inter- and intra-departmental customers to ensure device tracking information and inquiries are communicated appropriately.
• Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing “talking points” and communicating corporate policy.
Support department processes and workflow
• Process outgoing faxes, incoming mail, perform data entry, filing and copying.
• Initiate and process follow up activities to gather information, submit notifications, etc.
• Inform internal and/or external customers of the device tracking requirements.
• Ability to monitor several files at once, including status and follow-up as necessary.
• Respond to verbal and written requests from internal and external customers. Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files, following complaint handling regulations 21 CFR 820.198, and SOR/98-282, and internal procedures.
• Ability to identify non-complaint customers and forward to management for resolution.
25%
Provide assistance with various departmental projects that may include:
• Write/revise department procedures as assigned.
• Assist in the coordination of department personnel regarding device tracking and/or complaint handling activities to ensure compliance with applicable regulations.
• Develop training content.
• Train new staff and conduct training/re-training on company policies, Device Tracking regulations, complaint handling regulations, and departmental practices.
• Support the department on special projects as needed.
• Assist in device tracking audit activities.
• Support regulatory inspections.
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job. Education and Experience
• AA degree, with three to five years previous experience in regulatory, quality, clinical, or related customer service setting; or equivalent combination of education and experience. Bachelor’s degree is strongly preferred.
ESSENTIAL SKILLS:
• Knowledge in device tracking policies and requirements. Ability to understand the impact of regulatory compliance requirements (e.g. 21 CFR 821, 21 CFR Part 11, SOR/98/282 and other regulations as they apply)
• Ability to function in a controlled environment by the FDA and other regulatory authorities.
• Ability to communicate effectively, both verbally and in writing.
• Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
• Knowledge of clinical, surgical techniques and procedures, and medical terminology.
• Ability to work effectively with a diverse network of internal and external departments and/or individuals.
• Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
• Skill in demonstrating a professional phone manner.
• Effective communication with physicians and nurses as required.
• Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
• Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
• Ability to take initiative and make decisions.
• Ability to demonstrate leadership in job performance by example.
* Ability to accurately perform detail-oriented work.
• Ability to be flexible in changing daily workload priorities as directed.
• Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
• Ability to coordinate and synchronize multiple projects.
• Ability to monitor and coordinate department workloads.
• Ability to develop and deliver training.
• Ability to manage a high-volume case load.
• Ability to think critically and analytically.
What are the top 3-5 skills, experience or education required for this position:
Critical thinking skills to problem solve or identify when to escalate
Ability/experience in working both independently and as a team
Experience in working in a controlled/regulated environment (e.g. federal/state regulations, privacy)
Experience in customer service, especially communicating sensitive information over phone in email with tough calls
Minimum associate’s degree; bachelor degree preferred
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $22.00/daily.