Clinchoice Inc.

Health Authority Reporting Analyst

United States

Sponsorship not specifiedDetected 2 days ago

ExcelCustomer SupportFDA RegulatoryMedical DevicesCommunicationProblem SolvingMicrosoft OfficeMicrosoft Teams

About the role

Focus areas are Regulatory Reporting to FDA under 21 CFR, Part 803, Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1, Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.
Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations.
This may include assigning product experience and patient codes.

Demonstrate world class customer support and maintain knowledge of relevant Operating Company's products and services
Utilize MD Workflow reports to identify tasks and manage common Email inboxes.
Appropriately utilize risk management documentation to support the complaint's regulatory reporting process
Involved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicable
Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures

File Medwatch report forms within required timelines as applicable
File MDVs in accordance to EEA, Switzerland and Turkey, candidate countries and other third countries guidelines within the required timelines as applicable
Participate in escalation process as required
Knowledge of applicable quality, FDA (Food & Drug Administration)
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS *
Fluent spoken/written English required.

Strong written and verbal communication skills. Fluent spoken/written English required.
Strong decision-making skills - able to make sound business decisions with sometimes limited information
Ability to work in a cross-functional and matrix environment
Ability to work independently
Continuous Improvement focus
Time management.
Ability to handle multiple priorities/ sudden changes in priorities
Ability to work in stressful/fast paced environment
Ability to work and interact with co-workers to accomplish company goals in a team environment
Analytical/Problem Solving Skills
Ability to learn
Strong attention to detail

Health Authority Reporting Analyst
Completed apprenticeship or Baccalaureate degree, preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field or University/Bachelor's Degree or equivalent experience
2-4 Years related experience is desirable (A combination of experience and education can be allowed)
Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirements
Knowledge of human anatomy, medical terminology and products of applicable Business Units
Manage Standard Health Authority Requests of Health Authorities incl. justifications for non-reporting in accordance with FDA and EU regulations as applicable
Participate in the onboarding training of new associates and/or existing associates learning a new product

to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.
The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer.
We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity.
Be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Create and/or forward additional information follow up questions as part of complaint investigation. Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file management.

This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.