Product Surveillance Tech I

Product Surveillance Tech I
Company:

Software Guidance & Assistance


Product Surveillance Tech I

Details of the offer

Location: Austin, TX
Bill : $35.71 HR

Responsibilities:
Analyze information reported in order to conduct immediate follow up with complainant to obtain required information. Initiate and set up complaint files.
Maintain and update database.
Record all complaint activity in both hard copy (when applicable) and computer files.
Assess incoming information across all product lines for complaint data.
Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across all product lines are handled appropriately.
Receive information and respond to questions for on-going complaint investigations and update applicable records.
Maintain a knowledge and understanding of current MDR regulations, MDR guidelines, MDR interpretations, product labeling, other federal laws governing medical devices, Department of Transportation (DOT) requirements for explant returns, and the FDA mandated Retrieval Program.
Initiate and process product reimbursement and claim records.
Inform internal and external customers of reimbursement policy and product return requirements.
Contact internal and external customers if claim is incomplete.
Ability to monitor several cases at once, including status and follow-up as necessary.
Respond to verbal and written requests from internal and external customers for payment of warranty in a timely manner.
Ability to identify potentially litigious customers, and forward to management for resolution.
Provide generalized company, departmental and product knowledge as required.
Communicate with the Quality Assurance, Clinical Studies, Customer Care, Operations, Marketing departments, and manufacturing facilities.
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 the department on special projects as needed.

Requirements:
As a Product Surveillance Tech you must represent our company well by being responsible, punctual and motivated to go above and beyond the call of duty.
You must also be highly detail-oriented and organized with excellent analytic and problem-solving abilities.
It is also important that you display excellent verbal and written communication and interpersonal skills.
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; Bachelor's degree is preferred.
2-3 years previous experience in customer service or clinical setting; or equivalent combination of education and experience.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials) Ability to read, analyze, and interpret financial reports, medical reports, and legal documents.
Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
Ability to use word processing, spreadsheet, and database applications.
Ability to learn various software programs.
Ability to handle confidential data in accordance with HIPAA and related international standards.
Ability to function in a controlled environment regulated by the FDA and other regulatory authorities.
Knowledge of current MDR regulations, guidelines, and interpretations.

Vigilance reporting as prescribed within EEA, EAME, APAC and LATAM regions.

Includes Council Directive 93/42/EEC June, 1993 (Medical Device Directive) and other country/regional medical device regulation.

Expertise of any transpositions by countries within the EEA. Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 803 (MDR Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures).

ISO 13485:2016, ISO 14971, the Canadian Medical Device Regulations 1998, SOR/98-282, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.

Knowledge of clinical, surgical techniques and procedures, and medical terminology.
Skill in demonstrating a professional phone manner. Effective communication with physicians and nurses as required.
Expertise in complaint policies and requirements.
Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
Ability to learn about Medical products and procedures/techniques associated with their use.
Ability to take initiative and make decisions.
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 think critically and analytically to evaluate each record on a case-by-case basis.
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Requirements


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