Senior Regulatory Affairs Specialist

Overview

Senior Regulatory Affairs Specialist supporting Design and Development Control activities with regulatory requirements, and preparing document packages for international regulatory submissions.

What you'll do

• Lead development and maintenance of regulatory files, data, records, and reporting systems for systematic retrieval of information.
• Prepare, review, file, and support premarket documents for global registrations for assigned projects.
• Provide requested regulatory data and documents to support tenders.
• Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
• Compile all materials required in submissions, license renewals, and annual registrations.
• Recommend changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitor and improve tracking and control systems.
• Direct interaction with regulatory agencies on defined matters.
• Develop regulatory strategies for new or modified products for assigned projects.
• Monitor and provide information on the impact of changes in the regulatory environment.
• Communicate with regulatory agencies and/or notified 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.
• Author and/or review regulatory procedures and update as necessary.
• Coach peers on matters related to international submissions and other related regulatory programs.
• Identify opportunities for process improvements and organization for business impact and efficiency.
• Support internal audits and inspections.

What you'll need

• Bachelor's degree in medical, mechanical, electrical, life science, or other healthcare related majors.
• 7+ years of experience in regulatory affairs (RA) role in the medical device and/or pharmaceutical industry.
• Works independently with general supervision on larger, moderately complex projects or assignments.
• Contributes to the completion of project milestones.
• Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Communicates primarily and frequently with internal contacts to share information, status, needs and issues, gain input, and support decision making.

Nice to have

• Excellent communication and interpersonal skills.
• Excellent written, organizational, and communication skills, with a flexible and team-oriented attitude.
• Self-motivated and positive.
• Ability to quickly establish credibility with all levels of internal and external stakeholders.

Details

• Location: Nanakramguda, Hyderabad, India.
• Eligible for the Medtronic Incentive Plan (MIP), a short-term incentive.