Regulatory Affairs Reporting Specialist

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Job description

Kelly Science & Clinical is currently seeking a **Remote Regulatory Affairs Reporting Specialist** for a long-term engagement with one of our Global Med Device clients out of Warsaw, IN

*****This role is fully remote*****

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

**Regulatory Reporting Specialist**

Prepares and submits 3500A and MIR forms within required timelines.

Responsible and accountable for the accuracy of the submitted information in the regulatory reports.

Prioritizes work according to meeting regulatory reporting timelines.

May assist in training activities related to regulatory report submissions.

Assists in closure of records which are not related to product complaints.

Authors requests to surgeons, hospitals and patients for information related to adverse event reports.

Manages records returned from surgeons, hospital, patients and/or legal related to adverse event reports and makes the appropriate notifications to the complaint handling team.

Assist in the review of daily workflow reports.

Interacts positively with internal/external business partners and colleagues.

Adheres and complies with work instructions, standard operating procedures and regulations.

Completes all training on time.

Participates in CAPA/NC activities related to regulatory report submissions.

Proactive collaboration and resolution to cross-function issues with stakeholders.

Make or reassess regulatory reporting determinations and execute file reviews on applicable files.

Responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and applicable standards.

**Experience and Education**

Completed apprenticeship or Bachelor's degree, preferably Scientific, Medical, LifeScience, Health Science, Technical, or Engineering field

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 Joint Reconstruction products

**Why Kelly** **®** **?**

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()