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About the Role

You will lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Responsibilities include monitoring the company's drug and medical device surveillance programs, including intake, protocol development, evaluation, processing, and follow-up of adverse event reports, and participating in the resolution of legal liabilities and compliance with government regulations. You will also create and accurately maintain reports such as Medical Device Reports (MDRs), Drug Adverse Event (ADE) data, and adverse reaction data in accordance with regulatory agency requirements. Review and analyze clinical databases for ADE data extraction and integration, ensuring a unified database is created in line with ADE standardization and internalization goals and objectives, and that safety summaries are accurate and high quality. Serve as a liaison with internal and external collaborators to develop programs and processes that meet regulatory reporting requirements.

Responsibilities

Monitor the company's drug and medical device surveillance programs, including intake, protocol development, evaluation, processing, and follow-up of adverse event reports.
Participate in the resolution of legal liabilities and compliance with government regulations.
Create and accurately maintain reports such as Medical Device Reports (MDRs), Drug Adverse Event (ADE) data, and adverse reaction data in accordance with regulatory agency requirements.
Review and analyze clinical databases for ADE data extraction and integration.
Ensure a unified database is created in line with ADE standardization and internalization goals and objectives, and that safety summaries are accurate and high quality.
Serve as a liaison with internal and external collaborators to develop programs and processes that meet regulatory reporting requirements.
Provide and/or manage assigned projects and work with other stakeholders to achieve desired outcomes.
Act as a mentor to colleagues or direct the work of other junior-level professionals.
Spend most of the time providing and overseeing project delivery from design to implementation.
Make adjustments to systems and processes or recommend ways to extend them to improve problem-solving and efficiency within the job area.
Provide guidance and support to junior or support career stream employees.

Requirements

Typically requires practical knowledge in job area gained through advanced education and experience.
Bachelor's degree (or a higher degree with 0 years of experience) or a Bachelor's degree (or its foreign equivalent) and 2 years of relevant experience.
Must comply with all credentialing requirements at the hospitals or clinics they support.

Skills

Communication
Influence
Problem-solving
Efficiency
Mentoring
Guidance
Support
Data analysis
Database management
Regulatory reporting
Medical device surveillance
Drug surveillance
Adverse event reporting

Location

Remote

Work Type

Full-time

Experience Level

Professional
Individual Contributor

Education Level

Bachelor's degree
Higher degree

Salary/Compensations

Competitive Salary

Benefits

Flexible Benefits Package
Medtronic Incentive Plan (MIP)

About the Company

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 95,000+ 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.
We change lives.
Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes.
Our industry leadership comes from the passion and ingenuity of our people.
Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team.
With one Medtronic Mindset defining how we work.
Speed and decisiveness run through our DNA.
Diverse perspectives inspire our bold answers to any challenge that comes our way.
And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer.
By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning.
Experiences that put people first.
Respect for people is the hallmark of our humanity.
It fuels our team to positively impact even a single life.
And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies.
No matter your role, you contribute to technologies that transform lives.
What we build empowers patients to live life on their terms.
Better outcomes for our world.
Our Mission to improve human welfare drives us.
We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care.
Fresh viewpoints.
Cutting-edge AI, data, and automation.
You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care.

Equal Opportunity

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.