Associate Reg Ops Specialist.
Associate Reg Ops Specialist.
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Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
This position is part of the Regulatory Affairs Data and Product Release Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization supporting regulatory systems and processes. Primary responsibilities include supporting our Unique Device Identification (UDI) process and system to ensure global regulatory compliance and data integrity. Duties may include participating in projects supporting our Regulatory Affairs teams within the Operating Units and Regulatory Operations. This role primarily interfaces with regulatory affairs teams operating unit (OU) regulatory teams regulatory operations teams manager and director.A role in MCRS offers unique experience opportunities such as: being part of a global team collaborating with business partners throughout the company visibility to global structures and impacts and insight to various processes and functions across Medtronic.
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
This role is a hybrid position based in Bogota.
Responsibilities may include the following and other duties may be assigned:
Activities related to enterprise-wide regulatory management systems including systems coordination training developing and implementing plans and providing input to systems designs.
Performs Regulatory Operations activities including data transformation to support global UDI submissions
Collaborates with global regulatory affairs teams and operation units to gather and analyze required information
Participates actively in cross-functional teams to meet timelines resolve regulatory issues and improve work processes.
Required Knowledge and Experience
Bachelors degree
0 years of experience
Advanced proficiency in English
High learning agility
Organizational skills and highly detail oriented
Flexible with changing priorities self-motivated strong work ethic works well under pressure in a dynamic environment
Intermediate knowledge of spreadsheet and database applications (Microsoft Office SharePoint and Sitebuilder)
Analytical and problem-solving skills
Document interpretation queries and workflow skills
Excellent communication skills
Nice to Have
Experience in medical device
Experience with regulatory affairs or quality
Experience with UDI
Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
Advanced communications skills (written and oral)
Effective project management skills
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 95000 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
Required Experience:
IC
Employment Type
Full-Time
