Regulatory Affairs Specialist

Overview

Regulatory Affairs Specialist supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies, working in a team environment with all organizational departments.

What you'll do

• 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.
• 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.
• Document, consolidate, and maintain oral and written communication with health authorities.
• Prepare internal documents for modifications to devices, when appropriate.
• Compile all materials required in submissions, license renewal and annual registrations.
• Participate in health agency inspections and 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 and maintenance of regulatory files, records, and reporting systems for systematic retrieval of information.
• Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
• Ensure compliance to regulations specific to clearance and approvals of product raw material and/or prototype.

What you'll need

• Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors.
• 4-7 years experience for RA role in medical device and/or pharmaceutical industry.
• Good understanding of regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.
• Excellent written, organizational, and communication skills.
• Flexible and team-oriented attitude.
• Strong attention to detail and ability to handle multiple tasks.
• Good planning skills and ability to work under pressure.
• Good English, including reading, writing, and speaking.
• Good learning attitude.

Nice to have

• US and global regulatory affairs knowledge and experience.
• Experience working with cross-functional teams.
• Effective verbal and written communication skills both internally and externally.
• Experience solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Ability to work well under pressure in a dynamic environment.
• Highly organized, detail-oriented, and efficient.

Details

• Location: Nanakramguda, Hyderabad, India.
• A mix of medical device and pharma experience is preferred in case of pharma.