Your mission Indivi is a TechBio company enabling precision and personalised medicine to become a reality in neuroscience research and development. We are going through significant growth and looking for new team members who want to contribute to making our vision — making measurable what is not so — a reality.

Your profile As Head of Compliance, you will play a key strategic role in leading compliance and Quality Management System (QMS) initiatives for software used as Digital Health Technology (DHT), including:

• Data Collection and analysis as a Service –supporting pharmaceutical companies with digital endpoint data collection.
• Feasibility Studies – enabling the development of digital endpoints and associated mobile applications.
• If relevant: Medical Device Clinical Investigations – ensuring compliance and success in clinical validation.

This position is responsible for ensuring that our products and internal quality standards remain fully aligned with global regulatory requirements and client expectations.

Responsibilities:

Quality&Security Management/Assurance:

Regulatory Affairs:

• Oversee regulatory strategies for DHT and digital endpoints, ensuring compliance with relevant international regulations for theadoption and integration of digital measures in clinical trials, focusing on evidence generation and data integrity.
• Align with clinical development strategies from the science team, market strategies from the product team, and sales strategies from the business development team.
• Manage communication with regulatory authorities and notified bodies.
• Assist the Clinical Operations team in establishing and managing clinical trials, ensuring the integration of digital solutions complies with regulatory requirements and ethics.
• Align with the sales department on sales strategies to ensure all claims are compliant with regulatory standards and align with clinical team on available clinical evidence.

Legal oversight:

• Oversee international data privacy requirements and their implementation in the QMS through collaboration with the DPO.
• Collaborate with the business development team and external legal experts on alignment of legal questions related to contracting and quality agreements, if relevant.
• Collaborate withe the clinical data management team on legal requirements around data collection (e.g. EU data act).
• Maintain up-to-date knowledge of legal requirements that may impact the product.
• Company or contracting (e.g. sustains directive, Sunshine act etc) in collab legal experts.

Leadership Activities:

• Lead and guide a small team with direct reports and contractors, with the scope to adjust team size or external support based on the company’s evolving strategic requirements.
• Define and implement the best practices and tools necessary to achieve team goals efficiently and effectively.
• Facilitate a culture of open communication and decision-making, balancing discussion and decisiveness.
• Promote an environment where team members feel valued and heard, encouraging open discussions while also making timely decisions to move projects forward.
• Conduct performance reviews, provide regular and constructive feedback, and identify training and development opportunities to help team and Members grow professionally.

Necessary Competence (education qualification):

• Master’s degree in life sciences, engineering, or related fields.
• At least seven years of experience with quality management, information and regulatory affairs in a regulated industry, specifically inMedTech/Digital health, with a strong focus on software.
• Demonstrated knowledge and experience with Pharma GxP and, ISO 9001, and medical device framework (ISO 13485).

Needed skills:

• Excellent team player with a “can-do” attitude, comfortable in a multicultural environment and under pressure.
• Hands-on mentality.

About Us We are looking for highly motivated and experienced people with our like-minded focus on improving the lives of people with neurological disease.

Indivi is an equal opportunities employer and encourages applications from candidates of all backgrounds, particularly those from underrepresented groups. Reasonable adjustments will be made wherever possible.

https://indivi.io