Regulatory Affairs Specialist

Indotronix Avani Group; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading regulatory consultancy located in New Jersey is seeking an experienced Regulatory Affairs specialist. The role involves supporting US and EU regulatory submissions while ensuring adherence to regulations concerning medical devices. The ideal candidate should have over 7 years of experience in Regulatory Affairs, excellent knowledge of relevant global regulations, and proficiency in Microsoft Office. This position offers a chance to make a significant impact in the regulatory field.

Qualifications

• 7+ years of experience in Regulatory Affairs.
• Solid knowledge of global regulations for medical devices.
• Proven expertise using Microsoft Office Suite.

Responsibilities

• Support US and EU regulatory submissions.
• Track timelines and document milestone achievements.
• Understand global regulatory requirements for new products.

Skills

Regulatory Affairs expertise

Proficient in Microsoft Office Suite

Education

Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry)

Job description

• Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 7+ years of experience Regulatory Affairs required
• Support US and EU regulatory submissions (exercising judgment to protect proprietary information); track timelines and document milestone achievements.
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel