A Post Market Surveillance Specialist for a medical devices and equipment manufacturing company is needed in the Cary, IL area. This role manages the complaint handling and adverse event reporting process for drugs and medical devices by coordinating safety reviews, regulatory submissions, internal training, and communication with both customers and regulatory bodies.
location: Cary, Illinois
job type: Contract
salary: $23.06 - 31.36 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Perform safety reviews of product complaints to assess seriousness and determine resolution.
- Document and maintain records of all complaint investigations.
- Prepare and submit expedited reports on drugs and medical devices to U.S. and international regulatory bodies within required timeframes.
- Compile and submit PADER (Periodic Adverse Drug Experience Reports) and PSUR (Periodic Safety Update Reports) for drug products.
- Communicate verbally and in writing with external customers regarding complaints and inquiries.
- Review and approve investigations related to customer quality complaints.
- Communicate with internal stakeholders on complaint handling systems and regulatory reporting requirements.
- Conduct training on complaint and adverse event reporting processes.
- Licensed healthcare professional with clinical expertise.
- strong customer service orientation and willingness to assist stakeholders.
- Experience with complaint handling and TrackWise (preferred).
- Excellent written and verbal communication skills.
- High attention to detail.
- strong knowledge of FDA and international drug/device safety reporting guidelines.
- Familiarity with the company's product lines is a plus.
- Bachelor's degree in Nursing, Biomedical Engineering, Science, or related field (required).
- 5+ years (required).
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
