Regulatory Affairs Specialist

 Posted 3 hours ago
     
2-5 years experience
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AI Summary

The role involves assessing regulatory changes, coordinating projects, and analyzing operational data to ensure compliance and efficiency. The specialist will also manage data systems and support process improvement initiatives within the regulatory function.

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

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

Responsibilities may include the following and other duties may be assigned:

  • Assess and determine the impact of Regulatory Assessment Changes, providing guidance and recommendations when applicable
  • Follow up with Operating Units and RAC originators to clarify change information and ensure accurate interpretation of regulatory impacts
  • Coordinate and support regulatory projects, tracking milestones, priorities, and deliverables to ensure timely completion of assignments
  • Analyze and interpret regulatory and operational data to support decision-making and identify trends, risks, or opportunities for improvement
  • Utilize and manage regulatory and data management systems to monitor activities, maintain records, and ensure data accuracy and traceability
  • Identify opportunities for process improvements, including the development or support of automation initiatives and system enhancements that improve regulatory operational efficiency
  • Work independently and collaborate with other Regulatory Operations Specialists and cross-functional partners to support project execution
  • Contribute to regulatory efficiency by supporting the implementation of regulatory strategies and recommending improvements to systems and processes within the RA function
  • Track, monitor, and maintain records of daily activities, project progress, and metrics in the assigned regulatory tools
  • Provide guidance and support to entry-level team members when needed, helping ensure consistency and quality in regulatory assessments

Required Knowledge and Experience:

  • Bachelor’s degree in the medical field
  • 2 or 3 years of experience in regulatory affairs, regulatory operations, project coordination, data analysis, or a related field
  • Demonstrated ability to work independently on moderately complex assignments and manage multiple priorities
  • Experience analyzing and interpreting data to support operational or regulatory decision-making
  • Familiarity with data management systems, reporting tools, or platforms used for tracking regulatory or operational activities
  • Interest or experience in process optimization, digital tools, or automation initiatives that improve efficiency and data management
  • Fluent English

 

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 have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:

Medtronic will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.

If you suspect you have received a fraudulent offer or communication claiming to be from Medtronic, please do not respond, open any attachments, or click on any hyperlinks.

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
AskHR@medtronic.com.

 

 

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).

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