Clinical & Regulatory Affairs Intern

ONWARD Medical; Lausanne; On-site; CHF 19,000 - 29,000; Full time

Job summary

Hibob Inc. is seeking a Clinical and Regulatory Affairs Intern to collaborate with our team and an external partner to support clinical and regulatory activities.

You will help prepare study documents, ensure regulatory compliance with ISO 14155, and assist with data collection and reporting within our startup framework. You will work closely with clinical sites, perform literature reviews, and support regulatory submissions.

Qualifications

• Pursuing degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field.
• Strong organizational and communication skills.
• Detail-oriented with understanding of clinical trial processes and regulatory requirements.
• Proficient in Microsoft Office and data management tools.
• Self-motivated, proactive, able to work in a startup and help colleagues.
• Fluent in English; French language skills are highly desirable.
• Applicants must have a valid Swiss work/student permit or be eligible to work in Switzerland (Swiss or EU/EFTA citizenship).

Responsibilities

• Collaborate with the clinical and regulatory affairs team to prepare study documents and materials, supporting initiation of new studies and amendments.
• Work closely with clinical sites to ensure regulatory compliance with applicable regulations and standards.
• Collect and process field data, including adverse events and other study-related information, per the Quality Management System.
• Analyze and summarize data from clinical studies to support reporting and pipeline development.
• Conduct literature reviews to support clinical and regulatory activities.
• Assist the team with regulatory submissions, documentation, and compliance activities as required.

Skills

Organizational skills

Communication skills

Detail-oriented

English fluency

French desirable

Education

Life Sciences/Regulatory Affairs degree (in progress)

Tools

Microsoft Office

Data management tools

Job description

The Clinical and Regulatory Affairs Intern collaborates closely with the Clinical and Regulatory Affairs team and an external partner (NeuroRestore) to ensure the proper preparation, support, follow-up and overview of clinical activities and regulatory activities.

Responsibilities:

• Collaborate with the clinical and regulatory affairs team to prepare study documents, including protocols, Investigator Brochures, Case Report Forms (CRFs), and related materials, supporting the initiation of new studies and amendments integrating ONWARD Technology
• Work closely with clinical sites to ensure compliance with applicable regulations and standards (e.g., ISO 14155), promoting good clinical practice and effective data collection strategies.
• Collect and process field data, including adverse events, device deficiencies, and other study-related information, in accordance with ONWARD’s Quality Management System.
• Analyze and summarize data collected from clinical studies to support study reporting and provide rationale to guide ONWARD’s pipeline development.
• Conduct literature reviews and searches as needed to support clinical and regulatory activities.
• Assist the team with regulatory submissions, documentation, and compliance activities as required.

Job requirements

• Currently pursuing a degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field.
• Strong organizational and communication skills.
• Detail-oriented with an understanding of clinical trial processes and regulatory requirements.
• Proficiency in Microsoft Office and data management tools.
• A high-energy, fast-learner, self-motivated, pro-active personality able to work in a diverse team within a startup company; willing to help colleagues.
• Fluent in English, proficiency in French is highly desirable.
• Applicants must already hold a valid Swiss work/student permit or be eligible to work in Switzerland (Swiss or EU/EFTA citizenship)