Job Description
job summary:
This role offers a unique opportunity to transition your clinical expertise into the specialized field of medical device safety and post-market surveillance. You will play a critical role in patient safety by evaluating real-world device performance and conducting detailed medical assessments that influence global regulatory compliance. Operating out of a state-of-the-art facility dedicated to advancing medical technology and improving patient outcomes, you will join a team of experts focused on the highest standards of healthcare innovation.
In this remote capacity, you will bridge the gap between clinical practice and corporate safety standards. You will have the autonomy to manage your own caseload of safety assessments while collaborating with cross-functional teams to identify emerging trends and potential risks. It is a high-impact position designed for a detail-oriented professional who thrives on analytical problem-solving and wants to contribute to the safe evolution of medical devices.
location: Telecommute
job type: Contract
salary: $45.00 - 51.17 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Execute comprehensive Medical Safety Assessments (MSA) for medical device complaints, specifically focusing on reported adverse events.
- Determine the clinical seriousness of adverse events and assess the potential causal relationship between the device and the event.
- Evaluate recurring malfunctions to determine if they pose a significant risk of death or serious injury.
- Manage and prioritize a high volume of incoming assessments to ensure strict adherence to global regulatory reporting timelines.
- Conduct post-market safety surveillance for assigned product lines, identifying and escalating safety signals to management.
- Present findings regarding device safety data clearly in both written reports and oral presentations to key stakeholders.
- Ensure all activities remain in full compliance with corporate policies and international regulatory requirements.
qualifications:
Required Skills
- Bachelor of Science in Nursing (BSN) or higher.
- Active Registered Nurse (RN) license.
- Minimum of 5-7 years of direct, hands-on clinical experience in a healthcare setting.
- High proficiency with Windows-based systems, including Microsoft Word and Excel.
- Strong ability to translate clinical knowledge into data-driven adverse event assessments.
- Exceptional written and verbal communication skills for technical reporting.
Preferred Skills
- Previous experience in medical device safety, pharmacovigilance, or clinical research.
- Familiarity with post-market surveillance (PMS) regulations and complaint-handling workflows.
- Advanced clinical certifications or experience in high-acuity environments (ICU, ER, etc.).
#LI-ST1 skills: MS-EXCEL, Adverse Event (AE) Reporting, Periodic Adverse Drug Experience Report (PADER)
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, Remote work,