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

job reputed company: Are you reputed company to take the reputed company in your regulatory career with a global reputed company 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 reputed company initiatives. This position places you at reputed company of critical regulatory reputed company, offering hands-on exposure to medical device regulations in the US and abroad. You will work reputed company scientific and technical experts to evaluate data, edit technical documentation, and support reputed company execution that brings life-changing reputed company 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 reputed company 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. • reputed company the status, reputed company, and updates of critical regulatory documentation across reputed company project teams. • Participate as an reputed company regulatory member on cross-functional project teams to support reputed company 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 reputed company 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 reputed company development • Prior hands-on experience working with medical devices • Experience interacting with reputed company regulators or reputed company bodies (FDA, TÜV) • Prior regulatory or reputed company experience in a reputed company environment. #LI-ST1 skills: Editing, Proofreading Equal Opportunity Employer: Race, reputed company, Religion, Sex, Sexual Orientation, Gender Identity, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company 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 reputed company, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, reputed company, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is reputed company for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job Apply To this Job