Remote Regulatory Affairs Specialist - Medical Devices (FDA & EU)

job summary:
Are you ready to take the next step in your regulatory career with a global healthcare technology leader dedicated to advancing patient care through cutting-edge medical devices? In this role, you will play a key part in coordinating global submissions and ensuring compliance across international markets. You will be operating out of a remote work environment while seamlessly collaborating across cross-functional teams and key healthcare initiatives.

This position places you at the center of critical regulatory projects, offering hands-on exposure to medical device regulations in the US and abroad. You will work alongside scientific and technical experts to evaluate data, edit technical documentation, and support strategy execution that brings life-changing healthcare technologies to market.

location: Telecommute
job type: Contract
salary: $40.00 - 44.94 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Support the execution of global regulatory project plans and maintain compliant regulatory files.
• Compile and prepare draft responses to inquiries from external regulatory authorities according to plan.
• Review, evaluate, edit, and proofread technical and scientific data, reports, and departmental SOPs.
• Assist in the preparation, compiling, and review of product labeling and regulatory submission packages.
• Track the status, progress, and updates of critical regulatory documentation across active project teams.
• Participate as an active regulatory member on cross-functional project teams to support strategy alignment.

qualifications:

Required Skills & Qualifications:

• Bachelor's degree in a relevant scientific discipline (or country equivalent)
• Knowledge of basic scientific principles and regulatory concept
• Strong technical system skills (word processing, spreadsheets, databases, online research)
• Proven administrative, task prioritization, and project management skills
• Rigorous proofreading and editing abilities
• Strong interpersonal and written/oral communication skills.

Preferred Skills & Qualifications:

• Familiarity with USA (FDA) and OUS medical device regulations (specifically EU MDR/device regulations)
• Experience or exposure to regulatory strategy development
• Prior hands-on experience working with medical devices
• Experience interacting with external regulators or notified bodies (FDA, TÜV)
• Prior regulatory or quality experience in a healthcare environment.

#LI-ST1

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 [email protected].


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.