Senior Regulatory Affairs Associate - Bogota, Colombia - Ortho Clinical Diagnostics
Descripción
The Career Potential:
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures.
As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before.
There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics.
More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are.
If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
Major Duties & Responsibilities
- Maintain and update all Health licenses in Colombia, Panama, El Salvador, Guatemala, Puerto Rico, Costa Rica, Venezuela, and the Caribbean. Coordinate and obtain all legal and technical documents in support of regulatory submissions (new, renewal, modification, certification, etc) to ensure timely submissions accordingly to company needs.
- Maintain all regulatory registration data bases up to date (GTS, LATAM Change Tracker, Local databases, sharepoints).
- Manage productive relationships with regulatory consultants across North LATAM; provide clear direction on regulatory strategy and support documentation, to drive timely registrations in support of local Commercial strategy.
- Provide Regulatory information and support to Supply Chain, International Trade, Marketing and Sales departments.
- Control the period of validity of the regulatory documents, product licenses and ISO certificates.
- Asses and anticipate on the impact that the new regulations will have on the business and current licenses across region.
- Provide Regulatory documents and information when requested by the customers.
- Execute Technovigilance Activities and submit reports to the Local Health Authority.
- Execute Field Action Notification and Recalls activities, as well as, reports to the Local Health Authority, when applicable.
- Support the Local Health Authority Inspections.
- Pharmacy and Biochemistry, Pharmacy, Biomedicine or Biological Sciences degree.
- At least 3 years of experience in IVD (In Vitro Diagnostic), or Medical devices industry in Regulatory Affairs and advanced knowledge in the regulations related.
- Advanced user in Microsoft office, internet and knowledge in SAP system.
- English: Intermediate Level
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