Overview
Our client, a known sanitary materials distributor that just started to develop their business in Spain with a perspective of growing and build a team locally in the following months, is looking for a Regulatory Affairs / Registers Technician. (PART TIME JOB)
Responsibilities
* Regulatory Compliance :
Ensure compliance with Spanish and EU regulations for medical and surgical products, including preparing documentation to the Spanish Agency of Medicines and Health Products (AEMPS).
* Quality Management :
Maintain and oversee the quality management system to ensure adherence to the highest standards.
* Documentation and Liaison :
Act as the primary contact between the company and Spanish health authorities, particularly during the initial project phase.
* Collaboration :
Work closely with the company’s Business Development and Managing Chief and external regulatory consultants to ensure all legal and regulatory obligations are met.
Qualifications
* Educational Background :
A university degree in Nutrition, Health Sciences, Biomedical Engineering, or related fields is preferred. However, experience in similar roles will be highly valued.
* Experience :
At least 1 year of experience in regulatory compliance or quality management is required. Experience in medical devices or similar industries will be a significant advantage.
Skills
* Proficiency in Spanish and English (Catalan is a plus).
* Excellent attention to detail, strong organizational and communication skills, and the ability to bear responsibility.
Additional Requirements
* Telematic Work :
For the initial months, the role will be remote. Applicants must demonstrate that this arrangement will not affect their ability to fulfil the responsibilities of a responsible technical person.
* Regulatory Submission :
* After the candidate is chosen, their application will be forwarded to AEMPS for verification. This will include academic credentials, documentation of experience, and any other required materials.
Additional Information :
We are open to freelanceers.
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