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28 days old

Compliance Specialist Medical Devices (direct hire, Miami, FL)

Kelly Services
Miami, FL 33126
**Compliance Specialist Medical Devices (direct hire, Miami, FL)**


**Overview:** Kelly Services is seeking a motivated, hardworking individual to join our clients team as a Compliance Specialist. This is a direct hire role with a global company specializing in pharmaceuticals and medical devices.


The Complaint Specialist is responsible for the completion of all tasks associated with management and processing of event reporting, including communication for regulatory compliance with medical device reporting for both domestic and international agency regulations.



**Duties & Responsibilities:**


- Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability


- Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for products


- Write and submit eMDR reports to the FDA in strict adherence with regulatory requirements and timelines; performs MDR searches/queries.


- Write and submit MDPR reports to Health Canada in strict adherence with regulatory requirements and timelines; performs MDR searches/queries.


- Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information


- Maintain complaint and MDR file documentation in accordance with regulatory requirements.


- Completes global complaint handling and adverse event reporting activities related to products


- Provide support for internal quality audits of complaint files / MDR documentation, as well as external audits/inspections from Regulatory Bodies.


**Required Skills & Experience:**


- Bachelors Degree plus minimum 5 years experience in Quality, Regulatory or Complaint Management.


- MUST HAVE working knowledge of QA, Regulatory/Quality Compliance in a medical device industry.


- Able to utilize computers for development of reports and summary of project experience.


- Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook.


- Prior work experience with TrackWise Complaint Handling System preferred.


- Prior experience filing eMDRs preferred.


- Ability to work on multiple projects with various disciplines are essential.


- Position requires innovative thinking, ability to solve problems and meet deadlines.


- Strong communication, organization and presentation skills.



Please note that resumes from third parties will not be accepted. All candidates must be presently authorized to work for any employer in the US.


Apply today for immediate consideration or send your resume directly to


**Marina.Hart@kellyscientific.com**


**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-27 Expires: 2021-09-27

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Compliance Specialist Medical Devices (direct hire, Miami, FL)

Kelly Services
Miami, FL 33126

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