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.