Regulatory & quality compliance manager

Full-time

Job Description

At QMENTA, we strive to make brain diseases a thing of the past. With our powerful AI cloud platform and our state of the art machine learning algorithms, we take the most out of medical images in order to accelerate drug development and help experts and clinicians take precise and adequate decisions on the progress of a disease.

We are looking for an experienced and motivated Regulatory & quality compliance manager. You will lead audits and the submission for FDA 510(k) and CE mark. The position will play a key role in clearing the legal requirements to expand our business to the clinical care market. You will be responsible for maintaining Quality Management System and Information Security Management System to comply with the several industry standards.

Responsibilities
  • Prepare documentation for 510(k), CE mark and any other licensing
  • Maintain the status of US HIPAA, FDA Title 21 CFR Part 11&820, Annex 11, EU GDPR, ISO 13485 (Quality Management System for Medical Devices), IEC 62304 (Medical Device Software lifecycle)
  • Lead the internal/ external audits and interact with authority, consultants, or auditors
  • Coordinate corrective actions of problems on quality management and resolve non-conformance
  • Assure complaints from customers or internal users to be solved and follow the reporting procedures to authorities
  • Oversee the quality management process by making/reviewing the records
  • Collaborate internally with executives, the R&D team and the business team to facilitate the implementation of the defined procedures
  • Conduct internal training required by the regulations
  • Optimize the business processes to improve the productivity and communication across the teams
  • Create quality metrics to evaluate and monitor effectiveness of quality system
  • Maintain SOPs and policies by analyzing the software development procedures
  • Keep updated about the latest regulations and mitigate risks on the changes
  • Plan the compliance projects in the short and long term
Desired Skills and Experience
  • Hands-on experience developing 510(k) submissions and/or CE mark technical files
  • 5+ years of experience in quality assurance of software products
  • 8+ years of experience in related medical devices, pharmaceutical, or healthcare industries
  • Advanced knowledge of software development methodologies is a must
  • Understanding of cloud security
  • Working knowledge of Quality Management System (ISO 13485 and IEC 62304)
  • Working knowledge of Information Security Management System (ISO 27001)
  • Understanding of 21 CFR Part 11&820 regulations for medical devices
  • Understanding of HIPAA, EU GDPR, US/EU Privacy Shield and other related regulations
  • Understanding of 21 CFR 803 and MEDDEV vigilance
  • Exceptional technical writing skill
  • Familiar with approval workflow and electronic signature (e.g. DocuSign)
  • Project management skill
  • Ability to lead cross functional team
  • Driven. Multitasking. Detail oriented.
  • Advanced verbal and written English
  • Familiarity with a multicultural team environment
  • Desire to work in a fast-paced growth-stage startup
  • Bachelor’s or advanced degree in computer science or equivalent

To apply please send your resume to this address: qmenta-qmnt0038@applications.recruiterbox.com

Please attach your CV in English with your application. Non-English CVs will not be taken into consideration.