Director Clinical Affairs to Resitu
People Value AB / Civilingenjörsjobb / Uppsala
2025-12-10
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hela Sverige About Resitu
Resitu is an Uppsala based medical device company developing groundbreaking minimal invasive surgical devices for tissue harvesting. Our platform technology has the possibility to change how excisions are made, and with that dramatically improve patients' lives globally. Our first device, RESL09, is a minimally invasive ultrasound guided device intended to harvest breast tissue in patients with imaged breast abnormalities. Today, we are a small team of highly experienced professionals focused on making our technology available to doctors and patients worldwide. We are seeking an experienced Director Clinical Affairs with global experience (EU, US, and the Middle East/Africa), to lead the execution of Resitus' clinical investigations and evidence management globally.
The Role
As the Director Clinical Affairs, you are critical in the continued development of our Clinical Affairs function, with the responsibility of executing our clinical studies globally according to Resitus strategic plan. A key aspect is ensuring compliance with global regulatory requirements. You will lead the strategic planning and execution of clinical studies, post-market clinical follow-up (PMCF) activities, and the generation of clinical evidence necessary for regulatory approvals globally. This role requires a blend of clinical and scientific expertise, strategic thinking, and exceptional leadership skills to engage with cross-functional teams and external stakeholders. The role is based in Uppsala requires International travel up to ~40% of the working time.
Key Responsibilities
Clinical Study Management: Responsible for planning, coordination, and execution of clinical investigations and research initiatives, ensuring adherence to applicable regulatory standards.
Clinical Regulatory Submissions: Collaborate closely with other functions in the company to prepare clinical sections of submissions for e.g. EU, US and MEAa purposes.
Clinical Evidence Generation: Drive and lead the creation of clinical evidence and conduct systematic literature research for clinical evaluations and summaries of safety and clinical performance.
Team Management: Lead, mentor, and develop a high-performing clinical affairs team, fostering a culture of excellence and continuous improvement. Continue to grow Resitus clinical team to correspond to Resitus global clinical affairs strategy and needs.
Compliance & Quality: Overall responsibility for procedures and documents for clinical investigations and clinical evaluations. Ensure all clinical activities and communications comply with relevant ethical standards, industry regulations, and our Quality Management System (QMS)
Experience:
A minimum 10 years of documented professional experience in leading position of clinical affairs or clinical development function within the medical device industry.
Proven leadership experience with the ability to manage and develop multi-functional teams.
Demonstrated experience with global regulations, including ISO 14155:2020, Regulation (EU) 2017/745 (MDR), medical device related parts of the US CFR title 21, ISO 13485 and ISO 14971.
Documented experience in all aspects of executing clinical investigations in EU & US, and preferably also in MEA.
Documented experience in acting as author of Clinical Evaluations.
Documented training and Experience in maintenance of standard operating procedures related to clinical affairs.
Education: A PhD within a life science field is required.
Skills:
Strong strategic thinking, problem-solving, and decision-making abilities.
Excellent written and verbal communication skills in English, with experience presenting complex scientific data to diverse audiences.
High interpersonal skills and the ability to work effectively in a cross-functional, matrix environment.
How to Apply
If you are ready to join our team as a leader during an expansive and exciting phase of Resitus growth, please submit your application as soon as possible but at the latest December 28th 2025.
We review applications and conduct interviews on an ongoing basis. Welcome with your application!
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2026-05-29
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare People Value AB (org.nr 559232-0005),
http://www.peoplevalue.se Arbetsplats People Value
Kontakt Cecilia Hållner
cecilia.hallner@peoplevalue.se +46 709 50 41 00 Jobbnummer 9638399