Regulatory Affairs Specialist at Medtronic in Nanakramguda, Hyderabad, India

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

• 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.
• 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.
• Compiles all materials required in submissions, license renewal and annual registrations
• 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 OU developed product’s raw material and/or prototype.

Requirements

• 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. A mix is preferred in case of pharma.
• 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.
• 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 with solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Work well under pressure in a dynamic environment.
• Highly organized, detail-oriented, and efficient.

Skills

Required

• Good Learning attitude.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).