Clinical Affairs Specialist

Compremium AG is looking for a dedicated Clinical Affairs Specialist (80-100%) to support the setup, compliance, monitoring, and data integrity of our clinical studies and trials. In this hands-on role, you’ll work closely with cross-functional teams to manage the complexities of clinical trial compliance, and you’ll be directly involved in preparing documentation, managing relationships with regulatory authorities, and navigating both MDR and FDA regulatory pathways. Your contributions will extend from data management and monitoring to proactive safety reporting and training, ensuring our trials meet the highest standards of quality and ethics.

If you’re someone who takes an execution-oriented approach and are passionate about making a meaningful impact on the lives of patients and healthcare professionals, we’d love to have you join us on this journey to transform diagnostics.

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Study excellence: Ensuring that clinical studies and trials adhere to relevant regulations and standards, particularly with regards to GCP, MDR and FDA-guidelines. Contributing to Compremium’s interactions with external CROs as well as regulatory and ethical authorities for study approvals and submissions. This includes in particular the responsibility of preparing the documentation to be submitted for obtaining necessary ethics committee approvals, cross-functional collaboration with external regulatory consultants and ensuring that patient safety and rights are protected throughout the course of clinical trials.

Site Management: Managing relationships with site investigators and coordinators.

Clinical Data Management: Overseeing the collection and management of clinical trial data to ensure accuracy, consistency, and completeness. Ensuring data is collected by the sites and/or the appointed CRO in accordance with regulatory requirements.

Monitoring and Auditing: In collaboration with CRO, overseeing and performing the monitoring of clinical trial sites to ensure protocol compliance, accurate data collection, and adherence to regulatory requirements. Managing and performing internal and external audits as needed.

Safety Reporting: Managing the reporting of adverse events and serious adverse events that occur during clinical trials to regulatory agencies, ethics committees, and other relevant stakeholders.

Training and Education: Providing training and support to internal teams, investigators, and site personnel regarding clinical study procedures, and regulatory requirements and the safe use of the study devices.

Degree in Biomedical Engineering, Life Sciences or equivalent, with a specialization in Regulatory (MSc, PhD)

3-5 years of hands-on experience in Medical Device clinical trials (ISO 14155), the use of quality management system (ISO 13485), risk management (ISO 14791) and other relevant standards

Proven experience with EU MDR technical documentation preparation and FDA submission packages is a plus

Experience in statistical analysis is a plus

Proven experience of working in multi-faceted and international teams

Fast-learning

Self-motivated, ambitious and team-oriented

Impeccable English. German and French working proficiency are a plus.

On-site (in Muri bei Bern) with possibility of remote work

Willingness to travel (up to 20%)

In-depth knowledge of regulatory affairs and clinical trial management

Good understanding of Regulatory processes in Medical devices - Medical Device Regulation and FDA pathway in particular

Strong communication skills, with the ability to effectively convey information to diverse audiences

Strong writing skills (structured documentation such as protocols and reports)

Excellent interpersonal skills

Ability to work with internationally located team members in the organization

Demonstrates passion and enthusiasm for the company’s vision and work

Ability to manage/prioritize multiple projects and adapt to a changing, fast-paced environment