Regulatory Specialist

Designation : Regulatory Specialist

Experience : 7+

Location : Pune

Qualifications

Bachelor of Science in science and/or engineering field

8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)

Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards.

Experience in Orthopedics industry preferred.

510(k) experience and Regulatory Affairs Certification (RAC) preferred.

Ability to work under limited supervision with FDA, Notified Body, Authorized Representatives, 3rd party license holders and other global regulatory agencies.

Ability to support and execute activities related to product development teams and cross-functional projects.

Ability to work well with others and manage projects.

Excellent written and verbal communication skills. Proficient in Microsoft Office

Ability to read and speak English sufficiently to read, understand, and complete all documentation.

Mandatory Skills

Medical Device Regulations,FDA Medical Device Regulations,Regulatory Compliance,Medical Devices,Cross-Functional Teamwork