Regulatory Affairs Technician

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).

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.

#J-18808-Ljbffr