Associate Regulatory Operations Specialist
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.
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.
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 required
6 months to 1 year 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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .
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.
Required Experience:
IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 excit ... View more
