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 LifeSupporting 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.
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 HaveUS 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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
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).
Skills Required
- Bachelor's degree in medical, Mechanical, Electric, Life Science or other healthcare-related major.
- 4-7 years' experience in regulatory affairs within medical device and/or pharmaceutical industry.
- Good understanding of regulations and policies issued by India, US FDA and EU and ability to interpret international regulatory requirements.
- Excellent written, organizational, and communication skills; flexible, team-oriented attitude.
- Strong attention to detail; ability to handle multiple tasks, plan, and work under pressure; proficient English reading, writing, and speaking.
- Good learning attitude.
- US and global regulatory affairs knowledge and experience.
- Experience working with cross-functional teams.
- Experience with verbal and written communication externally and internally.
- Experience solving problems and concerns.
- Experience with project management and adherence to schedules.
- Ability to work well under pressure in a dynamic environment.
- Highly organized, detail-oriented, and efficient.
- Team player who seeks to help and learn from colleagues.
- Ability to manage projects to completion across departments.
- Strong interpersonal and negotiation/influencing skills while maintaining professionalism.
- Proactive development within the regulatory landscape.
- RAPS Regulatory Affairs Certification (RAC).
Medtronic Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.
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Parental & Family Support — Paid leave for birthing and non-birthing parents is positioned as notably generous, with additional Family Care Leave available for a range of caregiving needs. Fertility, adoption, donor, and surrogacy support adds depth for different paths to family-building.
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Retirement Support — A 401(k) match and an employee stock purchase plan are presented as meaningful long-term savings tools. Scholarship and tuition programs further reinforce financial security beyond salary.
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Healthcare Strength — Medical, dental, and vision coverage is consistently described as a strong part of the total rewards package. Mental health resources, critical illness coverage, and wellness supports broaden the overall health offering.
Medtronic Insights
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
