The Regulatory Affairs Operations Specialist will assist MITG RA Operations in the preparation and implementation of European Medical Device Regulation (EU MDR) requirements.
In this role you will be responsible for:
Serve as an MITG representative on the EU MDR RA workstream; assist in workstream compliance and harmonization across MITG
Assist in analysis of tech file and STED (summary of technical documentation) with goal of harmonization of one submission template
Develop a process to implement electronic tech file submission within Agile
Data entry and maintenance of remediation efforts within MP3; ensure the ramp-up in MP3 data is maintained correctly; maintenance of data for projects in-process, generating reports monthly and as needed
Participate in compliance activities that relate MITG
Compile information to generate bi-weekly, monthly, quarterly and yearly dashboards and/ or budget reports as needed
Perform other regulatory affairs duties when requested; while the initial focus will be on EU MDR for MITG, duties may include other programs and processes
Responsible for ensuring MITG commitments are met; and communicating program status as needed
Other duties as assigned with or without accommodation.
Must Have: Minimum Requirements
Minimum two years in the medical device industry focusing on Quality or Regulatory compliance
Experience/exposure with European Union submission
Good understanding to medical device regulations and policies
Registration experience on CE mark, 510K or registration
Proficiency in MS Word, Excel, PowerPoint, etc
Working knowledge of MS Project, internal systems including SharePoint, BOX, Agile
High learning aptitude and adaptability with software /internal systems
Excellent written and verbal communication skills
Highly organized, efficient and self motivated
Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure
Team player who seeks to help and learn from colleagues
Proactively seeks to develop and become well-versed within in the regulatory landscape
Nice To Have;
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
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.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.