Regulatory and Quality specialist

MiMARK is an awarded spin-off company focused on improving Women’s Health. We are specialized in discovering and validating clinically impactful biomarkers in gynecological fluids to provide innovative diagnostics across gynecology indications. In MiMARK we envision these fluids as the next step in liquid biopsy in the gynecological arena.

We are seeking for you!

We are seeking the Regulatory and Quality specialist in MiMARK. The perfect candidate is a geek for quality and organization who has experience in regulatory (CE mark and FDA) and quality management systems in a biotech, pharma, In Vitro Diagnostic (IVD), and/or medical device environment.
This position will be responsible for executing the regulatory strategy in MIMARK, including the definition and updating of Technical Documentation, and ensuring a global Quality Management System in the company in compliant with global standards and regulations.
You will have a unique opportunity to work with a highly passionate and committed team to bolster the regulatory pathway of IVD products to improve women’s health!

Responsibilities

Quality specialist

• Management of the quality system through all the company, including supervision, guidance and development.
• Update, improve, and promote the implementation of the global quality management system (ISO13485).
• Revision and update of the current Standard Operating Procedures (SOP), and strategically define and guide the new ones.
• Coordinate QMS reporting and audits.
• Prepare and issue the annual quality review reports.
• Provide a guidance to the Technical Team on scientific processes, product and process improvement, and new product development.
• Provide design review and risk assessment support.
• Support newly developed products transfer into the manufacturing environment.
• Provide input to specification input/output requirements.
• Support newly developed products on the transfer into the manufacturing environment.

Regulatory specialist

• Responsible for definition of the regulatory strategy for MIMARK products.
• Responsible for the communication with regulatory agencies (both FDA and EMA).
• Alienate the requirements for regulatory approvals with product development and validation stages. Actively communicate with Scientific, Technological and Clinical teams to work towards evidence generation.

Requirements

• University degree in Health Science
• Experience in a Quality and Regulatory in a regulated Healthcare environment (CE mark and/or FDA)
• Working knowledge of US, CE and international regulations (QSR, ISO, GLP, cGMP)
• Advanced level of English
• Passionate about order, responsible and perfectionist

We will value

• PhD in Health Science
• Regulatory clearance of medical devices by CE mark and /or FDA
• Experience in IVD development and validation

Benefits 

We would like you to profit from joining a team of talented people that share the passion to develop minimally invasive diagnostics based on gynecological fluids to improve women’s health. We would like to offer you a competitive compensation package: 

• Full-time job
• Incorporation expected by 4Q 2023
• Salary adjusted to the curricula of the candidate
• Great location in Barcelona (teleworking is optional)
• Flexible working hours, since we aim to balance the reconciliation of work and personal life with work responsibilities
• Entrepreneurial environment and a great team!

Selection process
The selection process will consist of a merit-based procedure in alignment with the Open and Transparent recruitment system of the European Commission. In brief, we will first check the eligibility criteria based on the candidate’s CV and by considering the requirements described in this job offer. Those passing this check will be interviewed. The selected candidate will be officially invited to join MiMARK’s team.