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

In this exciting role as a Quality Medical Writer in Medtronic’s Surveillance process within the quality and clinical organizations, the incumbent will contribute to the Post Market Surveillance, Post Market Clinical Follow-up and Clinical Evaluation document writing process to ensure compliance to regulations and expectations of Regulatory Bodies. This is a scientific (engineering, technical, medical) writing position. This individual will partner with other teams such as Quality/Reliability, Clinical Research, Regulatory Affairs, Product Development, Medical Safety, and Statisticians to collaborate and execute tasks in a timely manner.

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

• Contributes to portions of Post Market Surveillance, Post Market Clinical Follow-up and Clinical Evaluation plans and report documents that are authored by operating unit employee.

• Interface with Clinical and Post Market surveillance operating unit employees to obtain necessary information to complete tasks.

• Develop therapy and product knowledge and apply this knowledge to surveillance of products.

• May participate meetings to meet objectives.

• Provide input and feedback to ensure clear, concise complete reports.

• Collaborate with cross-functional team to assure high quality and successful completion of deliverables

• Report on schedule, timelines and deliverables

• Collect safety communications and compile reports

• Collect CAPA, FCA and IIA information and compile reports

• Review of key data elements to ensure no changes and consistency across various reports.

• Contribute or participate in drafting responses to deficiencies from regulatory agencies.

• Compiles, analyzes, and summarizes literature and additional data from other sources as needed.

• May participate in review activities and approval of other documents authored by another function

Required Knowledge and Experience

• Detail oriented

• Bachelor’s Degree in Engineering, Science, medical or technical field with 2+ years of work experience in Medical Writing, Engineering and/or Quality.

• Knowledge and apply this knowledge to post market surveillance of products.

• Medical device experience; or experience in a regulated environment

• Ability to identify customer/stakeholder requirements, and constructively respond to feedback/comments/inquiries

• Analyzes complex issues and significantly improves, changes, or adapts existing methods.

• Ability to work with very little direction towards predetermined long-range goals and objectives. `

• Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states, Neuromodulation therapies and technologies

• Ability to achieve objectives and milestones through identification and implementation of work plans and measurements.

• Ability to identify and adapt to shifting priorities and competing demands

• Knowledge and understanding of Good Clinical Practices, Post Market Surveillance, EU MDR Regulation, Quality Management Systems, Risk Management and other regulatory standards

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.

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 here (http://www.medtronic.com)

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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. That’s who we are. 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

These commitments set our team apart from the rest:

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 . Here, it’s about more than the bottom line. 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

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. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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