STARTASAP

DURATION7-9 months
We are looking for a Senior Medical Device Software (MDSW) Project Manager to lead the adaptation of an existing mobile app product to a new market within the medical device industry. This role requires a deep understanding of MDSW regulatory frameworks, design control processes, and quality management systems (QMS) to ensure compliance with medical device software standards in the target market in the context of an existing QMS.
As a MDSW Project Manager, you will be responsible for coordinating the localisation, regulatory adaptation, and technical modifications necessary to align the mobile app with the new market’s regulatory and compliance requirements. You will work closely with software development, quality assurance, regulatory affairs, and local market stakeholders to ensure a smooth transition and successful release.
The ideal candidate is highly organised, detail-oriented, and experienced in managing medical device software projects within regulated environments. You should be comfortable working with stakeholders across multiple disciplines, ensuring compliance with ISO 13485, IEC 62304, and ISO 14971 while managing timelines and project risks.

REQUIRED SKILLS

• Strong project management experience in software development, particularly within regulated medical device environments.
• Familiarity with design control and change control processes and associated QMS systems.
• Knowledge of ISO 13485, IEC 62304, and ISO 14971 standards for medical device software.
• Ability to manage adaptation projects, including localisation, regulatory modifications, and technical adjustments.
• Excellent communication skills, able to translate technical and regulatory requirements into actionable project plans.
• Experience managing timelines, deliverables, and risks in complex software adaptation projects.
• Strong documentation and reporting skills, ensuring transparency and compliance.
• Ability to work collaboratively with cross-functional teams, including regulatory affairs, quality assurance, and software engineering.

PREFERRED SKILLS

• Experience in adapting medical device software for international markets.
• Previous experience in regulatory submissions for medical device software in multiple regions.
• Understanding of mobile app development within the medical device or healthcare sector.
• Knowledge of Agile or hybrid project management methodologies in a regulated environment.
  Christian Drejø Jensen
  Senior Sourcing Specialist
  cdj@emagine.dk

• Lead the adaptation and localisation of an existing mobile app to meet regulatory and market-specific requirements.
• Ensure compliance with medical device software (MDSW) regulations in the new market.
• Manage design control and change control processes in alignment with QMS requirements.
• Collaborate with regulatory affairs teams to define and implement necessary changes for compliance with ISO 13485, IEC 62304, and ISO 14971 standards.
• Develop and maintain detailed project plans, timelines, and risk assessments for the market adaptation process.
• Facilitate cross-functional communication between development, quality, regulatory, and local market teams.
• Coordinate documentation updates, translations, and regulatory submissions as needed.
• Identify, assess, and mitigate project risks, particularly those related to regulatory compliance and patient safety (ISO 14971).
• Support audit readiness by ensuring all modifications and documentation meet regulatory and QMS requirements.