Regulatory Affairs Manager

About the company:

Altum Sequencing is a spin-off from Hospital 12 Octubre in Madrid. It was founded in 2019 by the Heads of the Hematology and Oncology Departments (Dr. Martinez López and Dr. Luis Paz Ares)

Altum has developed and patented a cutting-edge technology for assessing minimal residual disease (MRD) in cancer patients. This technology is focused on identifying cancer-specific genetic aberrations by NGS and detecting them after treatment in liquid biopsy. 

 Altum is already commercializing the technology worldwide. The company collaborates with international pharmaceutical companies, CROs, and research groups in developing novel liquid biopsy tests for unmet clinical needs. Altum has been awarded several competitive national grants to research and improve the current technology and expand it to other clinical applications for cancer patients' care.

Job Description:

We seek a regulatory affairs manager to lead our roadmap in CE-IVDR.

•Explain regulations, policies, or procedures

•Maintain data in information systems or databases

•Ensure compliance with regulations

•Advise others on regulatory and compliance matters

•Evaluate applicable laws and regulations to determine impact on company activities

•Provide technical review of data or reports

•Coordinate regulatory documentation activities

•Identify and interpret relevant regulatory guidelines

Desired Skills:

•Perfect writing and exceptional verbal communication skills

•Problem solving capacity. 

•Team leadership

•Self-taught person

Candidate Requirements:

• Advanced life sciences degree with knowledge about Next Generation Sequencing

• Master in Regulatory affairs for medical Devices CE-IVDR

• Experience ISO13485, IEC 62304 (recommended).

We offer

•Permanent contract

•Salary based on level of experience

•Joining a young and enthusiastic multidisciplinary team with a common goal: delivering personalized oncology tests to improve patients’ lives.