Regulatory Affairs Specialist

• 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;
• Good Learning attitude