Are you looking for an exciting remote opportunity in the medical device sector? A global healthcare leader is seeking a proactive Regulatory Affairs Associate I to support international project plans and submission preparations. This position offers a flexible schedule (supporting US time zones) and is ideal for an ambitious professional or motivated recent science graduate eager to build a high-impact career in Regulatory Affairs.
location: Telecommute
job type: Contract
salary: $40.00 - 44.94 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Coordinate and prepare global regulatory documentation, submissions, and responses for external regulatory bodies.
- Review, edit, and proofread scientific data, technical reports, product labeling, and SOPs for compliance.
- Maintain organized regulatory files and track document progress across multiple project streams.
- Collaborate closely with cross-functional project teams to collect documentation and meet critical milestones.
- Independently research regulatory requirements and solve project challenges with minimal supervision.
qualifications:
Required:
- Bachelor's degree in a relevant scientific or related technical discipline.
- Proven problem-solving capabilities, strong initiative, and ability to work autonomously.
- Excellent project management, organizational, and cross-functional teamwork skills.
- Proficiency with technical office systems, document databases, and proofreading.
- 1-3 years of Regulatory Affairs experience in medical devices, pharmaceuticals, or healthcare.
- Familiarity with US (FDA) and international (EU) medical device regulations.
skills: Editing, Proofreading
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.
