· orking under general supervision, reviews and investigates medical device complaints and maintains quality documents to ensure compliance with various regulatory agencies.
· Coordinates the resolution of complaints and ensures that timely investigations are performed.
· Takes initiative to ensure work is done accurately and completely.
· Problem solves recurring, routine situations; refers to senior level personnel for resolution of more complicated situations.
Career Level:
Commercial Compliance Analyst
Under the direction of the department manager, the Commercial Compliance Analyst may perform following:
· Support effectively on various compliance related initiatives and ongoing project tasks.
· This may include but not limited to working with cross functional representatives (e.g.: Regulatory, Technical services, Patient device tracking team etc.,).
· Main role would be supporting all the activities associated with Field Action that would include gathering the related communications and updating the progress of associated tasks and archive appropriately.
· It would also include timely communication of the activities to compliance and regulatory team and any escalation of specific issue immediately.
· Along with above, support all the commercial compliance project tasks as needed and as communicated by team project manager.
This includes providing requirements and input into scorecards for US commercial compliance, routine updates on process execution and improvement initiatives and develops and delivers training as required to reinforce compliance needs.
Job Requirements:
Required:
Qualifications:
· Education Level Major/Field of Study or Education Level:
· Bachelor’s Degree (16 years) Preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting medical device reporting, or product analysis.
· Degreed applicants without medical, scientific, or medical device reporting experience may be considered if they possess the strengths suitable for this position. OR an equivalent combination of education and work experience
Experience/Background:
· Experience/Detailed Knowledge of global regulations for medical device reporting and medical terminology is a plus.
· Strong written and oral communication skills are required.
· Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
· Good problem-solving and proficient computer skills are required.
· Experience working in a broader enterprise/cross-division business unit model preferred.
· Ability to work in a highly matrixed and geographically diverse business environment.
· Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
· Ability to leverage and/or engage others to accomplish projects.
Experience/Background Experience Details Multitasks, prioritizes, and· meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail
As an equal opportunity employer, ICONMA prides itself on creating an employment environment
that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual
orientation, citizenship, or disability.