The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients.
location: Telecommute
job type: Contract
salary: $40.00 - 46.74 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Medical device safety analytics
- Assisting with ongoing continuous improvement projects spanning across departmental needs
- SAE bulk review - periodic and individual reporting
- Responsible for individual and periodic medical device safety reporting
- Responsible for PI site notifications
- Providing support for training and automation efforts
- Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed.
- Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.
qualifications:
Required Qualifications:
- RN with US licensure
- 2+ years of clinical experience
- Clinical Medical device or combination product case processing (serious adverse events, SADE potential) experience
- Periodic case processing experience
- Proficiency in Microsoft Office (Excel, Word, etc.)
- Knowledge of Research & Development and regulatory guidelines (ICH, GCP, CFR, EU-MDR, safety reporting)
- Experience with EDC systems (Rave, RaveX, Veeva EDC, Oracle, Salesforce Applications)
- Strong multitasking, communication, and teamwork skills
- In-vitro device experience
- Data analysis and automation experience
- Experience with medical device safety reporting and risk management regulations
- Ability to influence others without direct reporting relationships
skills: MS-EXCEL, GCP (Good Clinical Practice), SAE (Serious Adverse Event), ICH Regulations
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 health, an incentive and recognition program, and 401K contribution (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.
