Associate Regulatory Affairs Specialist
hace 5 meses
**Careers that Change Lives
**In this exciting role as an Associate Regulatory Affairs Specialist, you will be in charge to prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned by Senior Supervisor or RA Manager. While being the focal point for Operating Units (OU) and countries under your scope about regulatory processes for all stakeholders.
You will help identify the requirements for local Ministry of Health (MoH) and provide guidance to centre-led team to plan timelines and registration strategies, including initial submissions, amendments, changes, and any other regulatory activities for Latin America (LATAM), following the instructions of the RA Manager and/or Senior RA Specialist.
**A Day in the Life
Responsibilities may include the following and other duties may be assigned:
- Ability to communicate clearly in writing and verbally with RA teams, Operating Unit (OU, other areas, etc.
- Review submission dossiers, renewals, and respond to government queries. Work with the RA Manager or Senior Supervisor to provide answers to those questions.
- Follow up with Business, Marketing, cross-functions, and Centre-led team Units to ensure submission planning.
- Collaborate with centre-led regulatory team on new product and changes that require submission and prior approval. Notify business partners, international, regional, and local teams of approvals.
- Verify and validate the information to be published in the databases.
- Attend any training related to local regulation provided by RA Local teams, consultants, etc.
- Provide the necessary information to create statistical reports and support budget preparation for LATAM countries.
- Keep up with changes in regulatory legislation and guidelines as an expert in the regulation.
- Maintain updated the Medtronic tool (Excel, Smartsheet) designated to track the progress of the regulatory processes.
- Participate in frequently strategic reviews with Internationals OUs, Business Partners, and RA Local Teams.
**Must Have: Minimum Requirements
- BA/BS degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience
- Advance proficiency in both Spanish and English required (reading, writing, and speaking)
- Minimum 1 year of relevant in the Regulatory Affairs field
- High proficiency in Microsoft tools
- Databases management
- Ability to work in matrix structured organization
- Document interpretation, queries, and workflow skills
- Excellent communication and presentation skills
- Analytical and problem-solving skills; Strategic thinking and decision-making skills
- Strong organization and time management skills Ability to work as a team
**Nice to Have
Desirable regulatory affairs experience in medical devices or pharmaceutical industry
**About Medtronic
**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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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