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Conmed Corporation
Medical Device Reporting Specialist
Job Location: Largo, FL
Qualifications:
High School/GED and 1 years' experience
Pay/Labor Grade: (not specified)
Salary: (not specified)
Paid Relocation Offered: N
Description of Duties/Qualifications
PRIMARY OBJECTIVE:
Provide decision making for manufacturers’ medical device reporting utilizing regulations, information and resources associated with the alleged product deficiency.
MAJOR DUTIES AND RESPONSIBILITIES:
1. Review domestic and international complaints on a daily basis to determine reportability based on FDA Regulations (MDR) and Medical Device Directive (MDD) reporting requirements and other regulatory bodies as required.
2. Generate sound rationale for non-reportable events based on clinical experience and/or regulatory knowledge.
3. Contact customers/other resources to aid in reportability decision.
4. Ability to process reportable events per required timelines.
5. Participate in Quality Systems Review Board and Corrective and Preventive Actions.
6. Perform Health Hazard Analysis using clinical experience to assess risk.
7. Provide clinical/regulatory expertise to design teams.
8. Responsible for maintaining high level of knowledge in products, surgical techniques, professional certifications/licenses as required.
9. Perform other duties as assigned or required.
QUALIFICATIONS AND JOB SKILLS:
1. Experience in the regulatory field or medical field:
Knowledge/experience in GMP/QRS regulations & MDR/MDD reporting requirements.
Knowledge/experience in the OR as Surgical Scrub Technician or Circulating Nurse.
2. Excellent interpersonal, verbal and writing skills.
3. Ability to work in a team environment.
4. Basic computer knowledge and word processing.
Application Form
Conmed Corporation
All candidates will be required to undergo drug screening prior to employment
Company Summary:
CONMED Linvatec is a leading medical device manufacturer of products for orthopedic and general surgery. We deliver surgical solutions to customers around the globe.
In 2007, Linvatec will be releasing the first true high-definition camera for the Endoscopy market. It promises to be a great year for our reps and our company.
EOE - M/F/D/V
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