Regulatory Affairs Specialist

hace 1 semana

Bogota, Colombia Medtronic A tiempo completo

**Careers that Change Lives**

**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.

**Must Have: Minimum Requirements**
- BA/BS degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience.
- 2 years of relevant experience in regulatory affairs or related areas.
- Fluent English level.
- Strategic thinking.
- Analytical and problem solving skills.
- Document interpretation, queries and workflow skills.
- Strong organization and time management skills.
- Decision making skills.
- Team player.
- Ability to work as a team
- Excellent communication skills.
- Knowledge in SAP.
- Knowledge in MS Office.
- Knowledge in Excel.
- Ability to work in matrix structured organization.

**Nice to Have**
- Presentation skills for small to mid-sized groups.
- Regulatory affairs experience in medical devices or pharmaceutical industry.
- Job experience as Associate Regulatory affairs Specialist.
- High understanding of market and laws for medical devices in Latin-American countries.
- Fluent Portuguese level.

**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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