job title: Regulatory affairs (saraca)

Roles and Responsibilities

Job ID: SS202500077

Function: Quality

Role: Regulatory Affairs

Desired Skills: Regulatory, EU-MDR, Document, International

Job Description

Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.

Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.

Develop Regulatory Strategies for new or modified products for assigned projects.

Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors

• Good relevant experiences for RA role in medical device and or pharmaceutical industry

• Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.