Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

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.

Required knowledge and experience:

• •Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors
• •4-7 year’s experience 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.
• 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 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).

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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Benefits & Compensation

• 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).