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Engaged Employer

Qure.ai

Compare

3.9

based on 32 Reviews

1 Qure.ai Regulatory Affairs Job

Director Quality & Regulatory Affairs

Qure.ai

3.9

based on 32 Reviews

7-12 years

Mumbai

1 vacancy

Director Quality & Regulatory Affairs

Qure.ai

posted 3mon ago

Job Role Insights

Flexible timing

Key skills for the job

Project Management AutoCAD Regulatory Affairs Compliance CCTV Monitoring QMS

+ 3 more

Job Description

Roles and Responsibilities

- Regulatory Affairs & Compliance Leadership:

- Act as the main regulatory liaisonwith global regulatory agencies for pre-submissions, submissions, andpost-market activities.

- Lead and oversee the development ofregulatory pathways, including clinical study design and regulatornegotiations.

- Remain current with evolvingregulations ( EU MDR, ISO 13485, IEC 62304, ISO 14971) and advise on strategicimplications.

- Quality Management System (QMS) Oversight:

- Ensure adherence to QMS policies andregulatory standards, including ISO 13485 and FDA guidelines.

- Manage internal and external audits,including preparation, resolution of findings, and coordination with auditinggroups.

- Oversee documentation for Correctiveand Preventative Actions (CAPA) and ensure it is communicated with allstakeholders.

- Cross-functional Collaboration & Strategy:

- Coordinate cross-functionalactivities to support product development, approval, and strategic planning.

- Partner with internal teams toexecute regulatory strategies for global market entry and compliance.

- Act as a regulatory affairs advisor,guiding research directions and influencing strategic decisions.

- Product Validation & Compliance:

- Develop and review validationdocumentation for SaMD and CAD devices to ensure regulatory compliance.

- Review product labeling, marketingmaterials, and customer statements for compliance and make recommendations.

- Regulatory Documentation & Monitoring:

- Assist in the preparation andsubmission of EU MDR filings.

- Conduct regulatory monitoringactivities to identify and respond to new or revised requirements, performingregulatory gap analyses.

What does success look like

Success in this role includes ensuring that our products meet or exceedregulatory compliance standards, that cross-functional teams are aligned withregulatory requirements throughout product lifecycles, and that regulatorypathways are efficiently navigated to support timely market entry andsustainable compliance.

Requirements

Proven experience in a senior regulatory role within an AI medical device company.

Extensive knowledge of EU MDR requirements, QMS, and medical device regulations.

Masterdegree (technical discipline preferred); RAC certification is a plus.

Strategic thinking with the ability to align regulatory needs with portfolio opportunities.

Strong project management and multitasking skills in cross-functional environments.

Exceptional written and verbal communication skills for clear documentation, presentations, and team discussions.

Demonstrated commitment to quality and continuous improvement, with a proactive approach to regulatory challenges.