Project Manager Digital Health (Remote)

Position Title: Project Manager – Digital Health (EMEA)

Location: Zagreb, Croatia

About Us:

Spectre Technology is a digital health company that improves the quality of life for patients with chronic diseases by delivering high-quality software and medical technology solutions. We act as a Critical Supplier/Subcontractor on projects developing software as a medical device (SaMD) and digital therapeutics (DTx) products under an ISO 13485-certified QMS. As a manufacturer of medical devices and IVDs, our company is registered in the Eudamed database under Actor ID/SRN HR-MF-000044251. We have an in-house process, and our expert teams handle every aspect of medical device strategy, product development, quality assurance, medical affairs, and regulatory compliance.

Job Description:

We’re looking for an experienced Project Manager – Digital Health (EMEA) to lead the design and implementation of regulated SaMD and DTx medical products. The successful candidate will oversee digital health solutions’ development, ensure compliance with industry standards and regulations, and collaborate with multidisciplinary teams to deliver high-quality software products.

Key Responsibilities:

– Lead the design and implementation of digital health solutions, including telemedicine, mobile health, and other regulated SaMD and DTx medical products.

– Collaborate with cross-functional teams, including clinical operations, data management, regulatory affairs, and R&D, to ensure the successful delivery of digital health projects.

– Define and document technical software requirements and processes to meet compliance standards, including data security and privacy per HIPAA, GDPR, ISO 27001, ISO 13485, and IEC 62304.

– Develop and maintain processes (SOPs), policies, and other documentation within our Information Security Management System (ISMS) and Quality Management System (QMS).

– Conduct regular audits to assess and enhance compliance within our ISMS/QMS and relevant regulations.

– Monitor and improve organizational and personnel compliance within our ISMS/QMS.

– Keep up with industry trends and best practices in compliance, data security, data privacy, and medical device regulations. 

Qualifications:

– Bachelor’s degree in Computer Science, Biomedical Engineering, or a related technical field.

– At least 5 years of experience in managing software projects, particularly in medical devices or digital health solutions, with a focus on regulated products in areas like oncology.

– In-depth understanding and hands-on experience with relevant standards and regulations, including ISO 13485, ISO 14971, IEC 62304, and IEC 62366, as well as GDPR and ISO 27001 for data security.

– Proven track record in leading projects from concept to commercialization, including planning, monitoring, and delivering within set timelines and budgets.

– Experience with agile methodologies such as Scrum or Kanban is advantageous.

– Ability to comprehend complex software systems and translate requirements into technical specifications.

– Experience with mobile application development (iOS, Android) and IoT devices is desirable.

– Excellent interpersonal and communication abilities for effective collaboration with multidisciplinary teams, clients, and external partners.

– Fluency in English; knowledge of German is a plus.

Monthly Salary:

€2,500 – €3,500 netto (varies by candidate experience)

40 hours/ per week

Application Process:

Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience to health@spectre-technology.com. Join us in our mission to revolutionize digital health solutions and make a meaningful impact on patient care. For more information about our company and services, please visit our website at [www.spectre-technology.com]