Sr. Post Market Surveillance Analyst

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JOB DESCRIPTION

Partial Job Description 1) Provide technical expertise in the areas of complaint handling, failure analysis and adverse event reporting 2) Work with engineers to perform standard and non-standardization failure investigations of returned products 3) Document and analyze complaint data for issues/trends 4) Enter complaints into the complain database in a timely manner, normally the same day received or the next business day 5) Send a complaint acknowledgement of receipt letter to physicians through the appropriate company sales representative as required 6) Determine under supervision if the complaint involves a reportable adverse event 7) Communicate with sales representatives, field service engineers, hospital risk management, physicians, Lab personnel, etc. in order to obtain the information required and to complete the complaint form and adverse event reports 8) Prepare under supervision, adverse event reports and send them to the appropriate regulatory body (FDA, competent authorities) within the required timeframe 9) Copy the appropriate notified body at the same time the AE is reported 10) Coordinate with field service engineers to obtain/clarify laser failure investigations 11) Complete all required documentation on the complaint form 12) Send an investigation summary report to the sales representative in order to review with they physician as required 13) Work with the company?s Receiving Department personnel to obtain returned devices 14) Perform decontamination process for all returned devices 15) Schedule and participate in failure investigations with post-market and the engineering groups 16) Forward the completed investigation form to the designated individual for completion and closing of the complaint 17) Provide input for product and process improvements based on failure investigations 18) Follow current policies and procedures to ensure compliance with all US and international regulations relating to complaint reporting 19) Participate in both internal and external quality audits (FDA, BSI, PMDA or others) 20) Perform complaint database searches for input to annual reports, submissions and corrective actions or as requested for engineering, sales/marketing, etc. 21) Maintain the MAUDE database reference book 22) Participate as a member of the safety committee 23) Perform routine cleaning of the decontamination lab, including floor mopping and wiping down all equipment and work surfaces 24) Maintain supplies of PPE and ensure replacement orders are places in a timely manner 25) Train others to perform these duties as required

CRITICAL REQUIREMENTS

  • Qualifications / Skills Required 1) BS/BA/associate?s degree with 4 years of experience in a regulated medical device environment 2) Minimum 2+ years of experience in medical device complaint handling, adverse event reporting and device failure analysis or 4 years as a Healthcare Provider (HCP) 3) Catheter Analyst experience ? a background as a Healthcare Provider (HCP) preferred (i.e. EMT - Medical Tech, etc.) 4) Laser Analyst experience ? a background in electronics or engineering technician preferred 5) Knowledge of US and international regulations for medical device manufacturers, including MDR and vigilance reports 6) Good understanding of quality concepts and tools 7) Proficient in Microsoft Office products

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Market Research
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.