Junior Regulatory Affairs Specialist

The Junior Regulatory Affairs Specialist, reporting directly to our Regulatory Affairs Manager, will be responsible for:

• Ensuring that the software and algorithms developed by Digitec comply with all applicable regulations and laws in the countries of interest.
• Ensuring that our products can be marketed within the timelines set by the organization and maintain their compliance throughout their lifecycle.
  

His/Her main objectives will be:

• Acquiring full knowledge of Regulation (EU) 2017/745, ISO 13485 standard, and the standards applied to our products (ISO 14971 and IEC 62304).
• Drafting the technical documentation of our products, ensuring compliance with current regulations and considering the company context.
• Learning to independently handle customers and address their regulatory inquiries

We are looking for candidates who stand out for:

• Problem-solving skills
• Proactivity and initiative
• Customer focus
• Precision
• Communication skills
• Teamwork

Like everyone at Digitec, the Junior Regulatory Affairs Specialist will promote the core values of our culture, namely Integrity, Vision, Teamwork, Innovation, Leanthinking and Bright.

The ideal profile, after obtaining a degree in Biomedical Engineering – or a related discipline – has gained an experience in a company, even briefly, in the regulatory field and must show interest in medical software.

What we offer:

• Innovative products and challenging work environment, constantly evolving
• Induction and Training program to enhance technical and soft skills
• Positive working environment where everyone is motivated to give his/her 100%
• Flexible working hours and opportunity to work from home (3Days/week and 1 full month/year remotely)
• Changing rooms and showers within Company premises that allow staff to train during their lunch break
• Free Coffee and company car park