10/19/2026 updated
100 % available
Project Manager | Regulatory Affairs | Medical Devices
Helsingborg, Sweden
Worldwide
M.Sc. in BiotechnologyAbout me
Project Manager with a Biotechnology background, experienced in coordinating 50+ international medical device and IVD regulatory projects. Skilled in cross-functional collaboration and stakeholder management, supporting manufacturers in bringing products to global markets.
BiotechnologyFinancial AnalysisProject ManagementRegulatory Affairs
I’m a Project Manager with a background in Biotechnology, experienced in managing international medical device and in vitro diagnostic (IVD) regulatory projects that help manufacturers bring their products to global markets. To date, I’ve successfully coordinated 50+ projects across Europe, Asia-Pacific, Latin America, and the Middle East, collaborating with cross-functional teams, clients, regulatory experts, and global partners.
At Pure Global, I support medical device and IVD manufacturers throughout their market access journey by coordinating regulatory registration projects across different countries. I work closely with clients, regulatory consultants, and international partners to ensure smooth project execution—from initial planning and documentation review to application submission and successful registration.
I enjoy bringing structure to complex and fast-paced environments, connecting people, improving processes, and keeping projects aligned with timelines, budgets, and deliverables. In addition to project coordination, I support the operational and financial aspects of projects by coordinating timely customer invoicing, tracking project revenue, and helping ensure successful outcomes for both clients and the organization.
With my foundation in scientific research and biotechnology, I am able to understand technical information and effectively bridge communication between regulatory experts, technical teams, business stakeholders, and customers.
I’m passionate about life sciences, healthcare innovation, medical devices, regulatory affairs, and market access. I enjoy working with teams that are developing meaningful healthcare solutions and contributing to innovations that create a positive impact.
I’m always open to connecting with professionals in project management, biotechnology, medical devices, IVD, regulatory affairs, market access, healthcare, innovation, and start-up ecosystems to learn, collaborate, and create meaningful impact.
Experience
Professional experience0 - 5 years
Freelancer since2024
Languages
EnglishNative speakerSwedishGood
Project history
- Managed 50+ international medical device and IVD regulatory registration projects across Europe, Asia-Pacific, Latin America, and the Middle East.
- Planned and monitored project scope, timelines, milestones, budgets, deliverables, and resources to ensure successful project execution.
- Coordinated cross-functional teams, regulatory consultants, international partners, and clients throughout the project lifecycle.
- Oversaw regulatory documentation workflows, submission preparation, application tracking, and registration activities across multiple markets.
- Facilitated project meetings, communicated progress updates, and managed stakeholder expectations.
- Identified project risks, resolved issues, and implemented corrective actions to minimize delays and ensure quality deliverables.
- Monitored project budgets, coordinated invoicing and payment follow-ups, and prepared monthly financial and performance reports.
- Improved project management processes, reporting, and documentation workflows using SharePoint and AI-enabled tools.
- Maintained strong client relationships and ensured alignment between regulatory requirements, project objectives, and business expectations.
- Coordinated QA, RA, and Clinical Evaluation projects for EU and US clients in the medical device and IVD sectors.
- Supported project planning, scheduling, task allocation, and progress tracking to ensure timely delivery of project milestones.
- Managed regulatory documentation, project records, and reporting activities in line with applicable requirements.
- Collaborated with multidisciplinary teams, including regulatory, quality, and clinical specialists, to coordinate project deliverables.
- Maintained effective communication between clients and internal technical teams to ensure alignment on project requirements, timelines, and expectations.
- Monitored project progress, followed up on outstanding tasks, and supported the resolution of documentation and coordination issues.
- Assisted with regulatory compliance activities and the preparation and review of technical documentation for medical devices and IVDs.
- Supported document control, workflow coordination, and quality processes to maintain accurate and complete project records.
- Contributed to efficient project execution by facilitating information exchange, tracking deliverables, and ensuring timely follow-up with relevant stakeholders.
- Performed skin tissue processing, preservation, and handling in accordance with established laboratory protocols and quality standards.
- Supported tissue engineering and burn research projects through laboratory experiments, cell culture, and sample preparation.
- Collected, analyzed, and interpreted research data to support scientific investigations and project outcomes.
- Contributed to scientific publications, including co-authoring a research paper related to burns.
- Conducted quality assurance checks to ensure accuracy, consistency, and compliance with laboratory procedures.
- Trained interns in laboratory techniques, skin processing procedures, and research practices.
- Prepared and delivered presentations to raise awareness about skin donation and its role in burn treatment.
- Collaborated with multidisciplinary teams to support research activities, project coordination, and timely completion of laboratory tasks.
- Assisted with customer and stakeholder interactions, providing relevant information and supporting effective communication.
- Maintained accurate laboratory records and documentation to support research integrity and quality management.