Details of the Organization

Clinvvo is a Swedish HealthTech SaaS platform founded by clinicians and technologists to digitize healthcare delivery through AI-driven workflows. The company provides clinical decision support tools trusted by leading providers in Sweden and is currently expanding across the European market. Clinvvo is dedicated to enhancing patient experience and reducing clinical costs by integrating cutting-edge AI into healthcare systems.

Details of the Job/Internship

Clinvvo is hiring a Legal & Regulatory Associate with experience of 1–3 years to join their office in the Greater Bengaluru Area

Role and Responsibilities

• Build and maintain the Technical Documentation (Annex II & III) required for CE Marking.
• Work with engineering teams to translate software architecture into compliant design inputs and risk management data.
• Lead the preparation of the Clinical Evaluation Report (CER) in accordance with MEDDEV 2.7/1 Rev 4.
• Establish and maintain a Quality Management System (QMS) compliant with ISO 13485.
• Define and manage SOPs and document control to ensure constant audit-readiness.
• Own the Software as a Medical Device (SaMD) classification rationale under Rule 11.
• Monitor regulatory updates from the MDCG and the EU AI Act regarding AI-driven medical software.
• Act as the primary point of contact for the Notified Body, managing submissions and queries.
• Drive the conformity assessment process to achieve Class IIa certification.

Eligibility

• Bachelor’s degree in Law (LL.B.) is mandatory.
• 1–3 years of hands-on experience in MedTech regulatory affairs, healthcare law, or consultancy.
• Deep knowledge of EU MDR 2017/745 and ISO 13485 standards.
• Technical literacy with the ability to understand software architecture and design.
• Preferred: Background in Life Sciences, Biomedical Engineering, or Biotech before law.
• Strong attention to detail and ability to work independently without a senior regulatory team.
• Familiarity with AI-powered legal research and drafting tools.

Salary/Stipend

Salary details will be finalised during the interview process with the selected candidate.

Type of Opportunity

Fulltime

Country

India

Address

Bengaluru, Karnataka, India

Application and Registration Details

We are solely providing this information for dissemination and wish to clarify that we are not affiliated with the organization.

After you submit your application, you will receive the next steps in the process via email. Please follow the instructions provided to complete your application. 

Stay informed about premier legal opportunities daily by joining our exclusive WhatsApp channel: https://whatsapp.com/channel/0029VaVAeN7J3jusbby2Ph33