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. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.Responsibilities may include the following and other duties may be assigned:
- Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.
- Prepare, review, file, and support premarket documents for global registrations for assigned projects.
- Provide requested regulatory data and documents to support tenders.
- Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
- Compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance.
- Monitors and improves tracking/control systems.
- May direct interaction with regulatory agencies on defined matters.
- 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.
- Author and/or review regulatory procedures and update as necessary.
- Coach peers on matters related to international submissions and other related regulatory programs.
- Identify opportunities for process improvements and organization for business impact and efficiency.
Required knowledge and experience:
- Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors.
- 7+ year’s experience for RA role in medical device and or pharmaceutical industry.
- Works independently with general supervision on larger, moderately complex projects / assignments.
- Contributes to the completion of project milestones.
- Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making.
Nice To Have Skills: - Excellent communication and interpersonal skills.
- Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
- Self-motivated and positive.
- Ability to quickly establish credibility with all levels of internal and external stakeholders.
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, electrical, life science, or another healthcare-related field
- 7 or more years of regulatory affairs experience in the medical device and/or pharmaceutical industry
- Ability to work independently with general supervision on moderately complex projects and assignments
- Ability to contribute to project milestone completion
- Ability to improve systems and processes to solve problems and increase effectiveness
- Excellent communication and interpersonal skills
- Excellent written and organizational skills
- Flexible, team-oriented, self-motivated, and positive attitude
- Ability to establish credibility with internal and external stakeholders at all levels
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.
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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.
