At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Post : Regulatory Affairs Specialist II
Job Description
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments.
Responsibilities may include the following and other duties may be assigned
• 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.
• Ensure compliance to regulations specific to clearance and approvals of MEIC developed product’s raw material and/or prototype.
Candidate Profile
• 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
Additional Information
Experience : 4-7 years
Location : Nanakramguda, Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th November, 2024
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