Senior Clinical Affairs Consultant - MedTech

Your Role
As a Senior Consultant within Clinical Affairs in our Comliance, Quality and Regularory team in Malmö, you will support our medical device and in-vitro medical device clients in developing and maintaining robust clinical evidence to meet the stringent requirements of EU Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746) and FDA regulations (21 CFR Part 820). You work independently in complex assignments and act as an expert advisor, strengthening our clients’ regulatory and clinical strategies throughout the product lifecycle.

In this role, you will play a key role in:
• Supporting regulatory submissions and the associated clinical documentation in accordance with the applicable conformity assessment procedures of (EU) 2017/745 (MDR), (EU) 2027/746 (IVDR) and FDA pathways including FDA 510(k), PMA, De Novo.
• Preparing, reviewing, and update clinical evidence plans, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Post-Market Clinical Follow-Up (PMCF) and Post-Market Performance Follow-Up (PMPF) plan and activities
• Conducting literature reviews, gap assessments, data and benefit-risk analyses to support ongoing compliance.
• Ensuring that clinical data is collected, analyzed, and reported in accordance with applicable regulatory requirements, international standards and relevant guidelines.
• Collaborating closely with QA/RA, R&D, and external clinical partners to support product development and lifecycle management.
• Planning, conducting, or monitoring Clinical Investigations.

Your Profile
• Degree in Life Science, Biomedical Engineering, Biotechnology, Biomedicine, or a related field, advanced degree preferred.
• At least 3 years of experience in Clinical Evaluation for medical devices and/or IVDs
• Strong knowledge of MDR 2017/745, IVDR 2017/746, FDA (21 CFR Part 820) and relevant standards, including clinical evidence requirements for CER and/or PER, PMCF and/or PMPF.
• Experience with risk management (ISO 14971), including performing risk analyses, assessing the benefit-risk of the device, and aligning clinical evidence with the product’s risk profile.
• Excellent analytical skills with the ability to interpret clinical data.
• Excellent communication skills in English (and preferably Swedish), both written and spoken

Application
As part of our recruitment process, identity verification or background checks may occasionally be conducted. 

Valid work permit for Sweden is required.
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