Clinical Specialist – Post-Market Surveillance Associate

MillenniumSoft Inc; Franklin Lakes (NJ); Remote; USD 80,000 - 100,000; Full time

Job summary

MillenniumSoft Inc is seeking a Clinical Specialist - Post-Market Surveillance Associate to join their team in Franklin Lakes, NJ. This role involves conducting post-market surveillance activities, providing technical counsel across departments, and ensuring compliance with medical device standards. Ideal candidates will possess a strong background in clinical laboratory science and have experience with customer interaction and product management.

Qualifications

• 3–5 years of experience in clinical laboratory science preferred.
• Practical knowledge with medical device safety reporting is a plus.
• Knowledge of IDS-Specimen Management products and instrumentation.

Responsibilities

• Conduct customer surveys for BD products following quality plans.
• Report product issues to the complaints team.
• Maintain relationships with customers and support complaint handling.

Skills

Communication

Problem Solving

Customer Service

Technical Skills

Education

BS Degree in medical technology, biology, chemistry, or other health sciences

ASCP or equivalent certification

Job description

Clinical Specialist – Post-Market Surveillance Associate

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Clinical Specialist – Post-Market Surveillance Associate

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Title: Clinical Specialist – Post-Market Surveillance Associate

Location: Franklin Lakes, NJ

Contract Term: 6+ Months

Shift/Hours: 1st Shift ( 8-9am to 4-5pm) / 40hrs

Client: Medical Device Company

Job Category: Sales Support

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

THIS IS A REMOTE ROLE UNTIL FURTHER NOTICE.

Job Summary

This position participates in Post Market Surveillance (PMS) activities with customers. The Clinical Specialist – Post-Market Surveillance associate will demonstrate technical skills in disciplines of clinical laboratory science such as specimen collection, clinical chemistry, hematology, coagulation, immunohematology, molecular diagnostics, urinalysis and urine culture, infectious disease and virology. Additionally, the associate will remain current in clinical laboratory science by participating in continuing education programs, and in department LEAN, Quality, and Continuous Improvement activities. As needed, the associate may offer technical counsel to Sales, Marketing, R&D, QA, and Regulatory Affairs.

Primary Duties, Responsibilities & Authorities

• Conducts customer surveys for BD products following the BD Vacutainer Tube Products Post Market Surveillance Quality Plan.
• Report product issues from customers to the BD complaints team and supports the complaint handling process.
• Establish and as needed maintain relationships with customers, dealers, distributors, IDS sales reps, country managers, product managers, regional technical specialists, and other functional areas to perform position functions.
• Maintains detailed practical knowledge of specific products as they relate to new and existing instrumentation, new diagnostic tests, etc.
• Works on issues where analysis of situation or data requires review of relevant factors.
• Exercises judgment within defined procedures to determine if additional actions are needed by other functions in the organization.
• Documents all customer inquiries and related activities in the identified validated system of record for Technical Support according to established work instructions and job aids.
• Provides customer product leads to BD Specimen Management associates for potential sales opportunities.
• Works in conjunction with the BD Specimen Management associates to win, defend, and grow the BD IDS business.
• Attends relevant meetings to obtain Quality and Regulatory updates.
• Participates in case studies sessions to develop and enhance troubleshooting and problem- solving skills.
• Attends at least one educational session per year to stay abreast of current technology and trends in clinical laboratory science.
  
  

Knowledge And Skills

• Ability to understand and translate customer issues and provides solutions.
• Good communications skills, both written and verbal.
• Ability to work cross-culturally.
• Proficiency with PCs and software such as word-processing and spreadsheet applications.
• Ability to make good use of minimal resources.
• Ability to coordinate multiple activities, visualize future steps.
• Able to communicate with technical and non-technical persons.
• Ability to utilize tact and diplomacy in dealing with people.
• Excellent customer service skills.
• Good background in problem solving.
• Knowledge of specimen collection and management techniques.
• Knowledge of the preanalytical phase of the total laboratory testing process.
• Knowledge of scientific methodologies and clinical laboratory medicine.
  
  

Education And Experience

• BS Degree in medical technology, biology, chemistry, or other health sciences.
• ASCP or equivalent certification preferred.
• 3–5 years of experience in various aspects of clinical laboratory science preferred. Practical knowledge and experience with medical device safety reporting is a plus. Knowledge of IDS-Specimen Management products, related competitor products, and clinical laboratory instrumentation are strongly desired.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

• Industries

  Staffing and Recruiting

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