Job Description
job summary:
Are you a licensed RN with specialized expertise in medical device risk management and post-market surveillance? A top-tier global medical device leader is seeking a detail-oriented Medical Reviewer/Safety Reviewer III for a 1-year, fully remote contract position. In this role, you will play a critical gatekeeper role in evaluating complaint reports, handling medical assessments, and ensuring compliance with global safety regulations.
location: Telecommute
job type: Contract
salary: $45.00 - 51.17 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Collect, review, assess, and process medical device adverse event reports and clinical study device deficiencies in alignment with global regulatory standards.
- Perform post-market portfolio medical assessments and escalate complex safety data to Medical Device Safety Physicians as needed.
- Maintain up-to-date knowledge of medical device and combination product risk management regulations, standards, and guidelines.
- Support safety surveillance, database reconciliations, and audit/inspection readiness activities.
- Coach and mentor assigned medical device safety personnel on routine safety tasks and deliverables.
qualifications:
Required: - Active, unrestricted U.S. RN License (Valid License #, State of issuance, and current City/State must be stated at the top of your resume).
- Bachelor's degree in Nursing (BSN), Health Sciences, or Engineering (or equivalent medical device industry experience).
- 4-7 years minimum of direct medical device safety experience.
- Strong working knowledge of Electronic Document Management Systems (EDMS such as Oracle Clinical or OneTrack) and Microsoft Office Suite.
- Proven ability to evaluate medical data critically and communicate findings effectively to clinical leadership.
#LI-AO1 skills: Drug Safety, Adverse Event (AE) Reporting, Case Processing, Medical Device, Medical Device Regulation (MDR)
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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Job Tags
Hourly pay, Contract work, Temporary work, Work experience placement, Work at office, Remote work