Launch your career with a leading global medical device organization as a Regulatory Affairs Associate I. This 100% Remote contract position offers an exciting entry point into global regulatory operations within Healthcare Systems & Technologies. You will collaborate closely with cross-functional teams and senior regulatory leaders to support global submission preparations, technical documentation reviews, and regulatory strategy execution.
location: Telecommute
job type: Contract
salary: $39.00 - 43.93 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Compile, track, and organize technical documentation for global regulatory submissions.
- Collaborate with cross-functional team members to gather scientific data and ensure project alignment.
- Assist senior regulatory staff in preparing responses to regulatory authorities (e.g., FDA, TUV).
- Edit and proofread labeling, SOPs, and departmental technical documentation.
- Maintain organized regulatory files and track document progress in alignment with project deadlines.
qualifications:
Required:
- Bachelor's degree in a scientific discipline or equivalent field (non-scientific degrees accepted with relevant coursework/training).
- Strong problem-solving, project management, and multitasking abilities with high attention to detail.
- Excellent interpersonal and communication skills for cross-functional collaboration.
- Proficiency in technical computer applications (spreadsheets, databases, word processing).
- 1 to 3 years of regulatory affairs experience, or a relevant Master's degree.
- Knowledge of US and OUS device regulations (specifically EU device regulations).
- Prior exposure to medical device, pharmaceutical, biotech, or diagnostics environments.
skills: Editing, Proofreading, Regulatory Affairs Operations, 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.
