Clinical & Regulatory Affairs Intern

ONWARD Medical; Lausanne; Vor Ort; CHF 20.000 - 29.000; Teilzeit

Zusammenfassung

ONWARD Medical seeks a Clinical and Regulatory Affairs Intern to support clinical and regulatory activities in collaboration with NeuroRestore. The role involves preparing study documents, ensuring ISO 14155 compliance, and contributing to data collection and submissions.

Ideal candidates are pursuing life sciences or regulatory fields, fluent in English with French desirable, and eligible for Swiss work/study permits. Lausanne-based startup environment offers hands-on regulatory exposure.

Qualifikationen

• 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)

Aufgaben

• Collaborate with the clinical and regulatory affairs team to prepare study documents, including protocols, Investigator Brochures, Case Report Forms (CRFs), and related materials.
• 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.

Kenntnisse

Organizational skills

Communication skills

Detail-oriented

Fast learner

Proactive

English fluency

French desirable

Swiss work permit eligibility

Ausbildung

Pursuing degree in Life Sciences / Biomedical Engineering / Regulatory Affairs

Tools

Microsoft Office

Data management tools

Jobbeschreibung

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 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)