Senior Regulatory Affairs Specialist

at  Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Are you ready to join a dynamic and energetic team? We’re seeking a passionate and innovative professional to join us, and collaborate with both subject matter experts (SMEs) and seasoned project/process improvement colleagues. In our small but mighty team, your ideas and contributions won’t just be heard—they’ll drive meaningful change and growth. If you’re eager to blend your skills with a team, drive impactful change within a collaborative and innovative environment, and value creativity, efficiency, and excellence, we want to hear from you!
We are looking for a QRA professional with understanding of the MDR and a knack for navigating complex matrix QA structures. Your contribution will be pivotal in ensuring compliance. The ideal candidate will also show a keen interest in process improvements, contributing to the continuous enhancement of our operations.

Responsibilities may include the following and other duties may be assigned

• Review & Enhance QA Structure: Conduct a thorough review of existing MDR QA regional structures, identifying areas for improvement, and implementing enhancements.
• Review & Enhance the risk management plan for Economic Operators, identifying potential risks & mitigations.
• Coordinate with Cross-Functional stakeholders to gather necessary information, provide regulatory guidance, and ensure alignment on project timelines and requirements.
• Maintain comprehensive documentation and evidence to support audit defensibility, ensuring that processes and procedures can withstand regulatory scrutiny and audits.

Must Haves

• Solid understanding of the Medical Device Regulation (MDR)
• Systems Agility
• Ability to navigate complex QA matrix structures
• Experience in a similar industry or related field
• Action oriented
• Solid command of English
• Excellent Communication and interpersonal skills
• Flexibility and adaptability in a fast-paced environment
• Ability to work independently and take initiative

Nice to Haves

• Knowledge of other regulatory requirements
• Proficiency with relevant software and tools
• Familiarity with agile methodologies or other project management frameworks

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.
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).
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity
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• Review & Enhance QA Structure: Conduct a thorough review of existing MDR QA regional structures, identifying areas for improvement, and implementing enhancements.
• Review & Enhance the risk management plan for Economic Operators, identifying potential risks & mitigations.
• Coordinate with Cross-Functional stakeholders to gather necessary information, provide regulatory guidance, and ensure alignment on project timelines and requirements.
• Maintain comprehensive documentation and evidence to support audit defensibility, ensuring that processes and procedures can withstand regulatory scrutiny and audits