Regulatory Affairs Specialist II - Hyderabad

A Day in the Life Careers that Change Lives

Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities and grow as we grow. Regulatory Affairs Specialist-II
A Day in the Life Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments.

• 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.
• 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.

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

Nice to Haves

• 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.
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Ability to manage projects to completion within and outside of the direct department and company.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• RAPS Regulatory Affairs Certification (RAC).

About Medtronic
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. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.