WANTED: Best Med Device Complaint Researcher Ever!

MEDICAL DEVICE REPORTING SPECIALIST Gathering information from the customer and making analytical, technical judgments about that information your strong suit? We need you!  ConMed Linvatec is seeking a detail-oriented Med Device Reporting Specialist to work in our complaint reporting department.  If you have experience analyzing compliant data with regard to FDA Regulations (MDR) and Medical Devise Directive (MDD) requirements, this could be your chance to build a rewarding career in the most exciting, high-growth industry today. PRIMARY OBJECTIVE: In line with manufacturer’s medical device reporting guidelines, receive (via phone from end users) incoming data, make decisions and write reports utilizing regulations, information and resources associated with the alleged product deficiency.  Participate as a SME on design teams. 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. Provide clinical/regulatory expertise to design teams. 6. Perform Health Hazard Analysis using clinical experience to assess risk.8. Responsible for maintaining high level of knowledge in products, surgical techniques, professional certifications/licenses as required. QUALIFICATIONS AND JOB SKILLS:1. Experience in the regulatory field or medical field: Knowledge/experience in GMP/QRS regulations & MDR/MDD reporting requirements. Candidates with knowledge and/or experience in the OR as a Circulating Nurse or Surgical Scrub Technician considered highly competitive.2. Excellent interpersonal, verbal and writing skills.3. Ability to work in a team environment.4. Basic computer knowledge and word processing. To apply:  email your resume to Lisa Krecklow, lkrecklow@linvatec.com ; or visit our career page at: http://www.ConMed.com Medical Device Reporting, MDR, Medical Device Directive, MDD, FDA, complaint, reporting requirements, quality, Operating Room, OR, Surgery, Surgical, surgeon, Good Manufacturing Principles, GMP, QRS regulations, Surgical Technician, OR Nurse, Circulating Nurse, medical device, FDA Quality System, investigation, complaint handling activities, risk assessment, complaints administrator, hospital, compliance,   Company: Linvatec Corp. Location: Largo, FL 33773 Salary/Wage: ConMed Linvatec offers a competitive compensation package including health, dental, life and disability insurance, 401K match, tuition reimbursement, generous paid holidays and more! Status: Full Time, Employee Job Category: Manufacturing/Production/Operations Relevant Work Experience: 2+ to 5 Years Career Level: Experienced (Non-Manager) Industry: Biotechnology/Pharmaceuticals;Manufacturing - Other;Healthcare Services Education Level: Associate Degree Occupations: Equipment Operations;Telecommunications Administration/Management;Scientific/Technical Production Industry: Biotechnology/Pharmaceuticals;Manufacturing - Other;Healthcare Services Contact: Lisa Krecklow Email: Apply by Email Reference Code: MDRS - QA