Prepare, review, file, and support premarket documents for global registrations for assigned projects.
Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
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.
Monitor and provide information pertaining to impact of changes in the regulatory environment.
Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
Document, consolidate, and maintain oral and written communication with health authorities
Prepare internal documents for modifications to devices, when appropriate.
Participate in health agency inspections & notified body audits as necessary.
Author and/or review regulatory procedures and update as necessary.
Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.
Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
Minimum Qualifications:
Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
4-7 years 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.
Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure; Good at English, including reading, writing, and speaking;
