Petar Blažević Email & Phone Number

Jena, Thuringia, Germany

Responsible for managing and writing Clinical Investigation & Evaluation Plans, Clinical Investigation & Evaluation reports, Post Market Clinical Follow Up plans and reports, SSCPs and any other clinical documentation required for continued CE marking and for FDA, Canada, Australia and other regulatory marketing authorities.Support R&D in pre-clinical research and related documentation and review promotional material to ensure that claims are substantiated by clinical data and appropriate safety information is included.Safety reporting of adverse events (AEs) and monitor and oversee study databases completion and data integrity.Clinical Support of Risk Management Team in risk assessment and implementing mitigating measures.Clinical SOP development and continuous SOP updates according to applicable regulations and standards. Preparation and follow-up of investigation site(s) for regulatory and quality audits as well as clinical studies. Managing and writing clinical investigation protocols and Ethics submissions.

Jena, Thuringia, Germany

Manage and write Clinical Evaluation Reports and Plans (CER/CEP), Literature Search Documents, PMCF Plans-Reports, Summary of Safety and Clinical Performance, Clinical Safety Management documents of products in accordance with EU MDR, FDA and other applicable medical device regulations. Integrate quality & regulatory changes into clinical documentations efficiently. Evaluate safety reporting of studies with collaboration of Clinical Data Manager and Clinical Project Managers of studies. Collaborate with all other relevant Occlutech departments to support life cycle management of medical devices. Developing and implementing clinical trial plans with CRM and CPM. Interpreting data for clinical activities and providing other medical support to maximize the company’s potential. Researching, collecting, presenting and offering expert opinion on scientific, medical and regulatory information to support both internal and external customers. Managing the integrity and accuracy of scientific, medical and regulatory data communicated both internally and externally including delivering appropriate training. Identify and develop strong, sustainable relationships with external Opinion Leaders to deliver both opportunity and provision to execute the product strategy. Provide regular updates to CRM on product-trial status.

Jena, Thuringia, Germany

Responsible for and ensuring the risk management process for medical devices according to ISO 14971:2019 within the product development process, planning, preparation and life cycle.Providing Regulatory knowledge and support in MDD – MDR transition in accordance with regulatory authorities. Lead risk management for product compliance and support active problem solving for critical issues. Creation and update of the risk management file (RMP, DRA, BRA, RMR). Performing risk assessment for complaints, adverse events, CAPAs etc. Assessing and giving input to clinical evaluation, R&D, marketing, sales etc. Introduce and maintain appropriate document management and reporting system. Maintenance and further development of the risk management process and the associated tools for non-clinical and clinical development, registration process and post-marketing. Support the Clinical Affairs, Product Management and Research & Development to define e.g. intended use, AEs, warnings and other relevant safety information in the Instructions for use (IFU) and clinical documents (CEP/CER) and evaluate and align the information in the risk management file - Support to creation and maintenance of safety documentation e.g. summary of safety and clinical performance (SSCPs).

Jena, Thuringia, Germany

As a Medical Device Safety Officer deputy perform vigilance activities (e.g. review and assessment of customer complaints regarding notification to NCA) - Initiation and coordination of necessary activities in line with international regulatory requirements (e.g., notifi cation of authorities, information of users, recalls, corrections) - Initiation of FSN, FSCA process regarding device safety issues.

Medicines And Medical Devices Agency Of Serbia

- Evaluation of the clinical and preclinical documentation and benefit/risk assessment for Marketing Authorization and for Renewal of the Marketing Authorization of medicines, clinical trials, medical devices, assessment of changes to the product information (SmPC and PIL variations).- Evaluation of the clinical and preclinical documentation and benefit/risk assessment for the approval of the clinical trials in R. Serbia.- Assessment of the efficacy, safety and quality of medicines as a member of the Committee for the Renewal of the Marketing Authorization of medicinal products- Deputy Manager at Efficacy and safety assessment Department ALIMS - Medicines and Medical Devices Agency of Serbia, January 2012. - July.2012.;

Clinical Pharmacology And Toxicology

Specialization in Clinical Pharmacology and toxicology at the University of Belgrade Faculty of medicine.

Doctor Of Medicine - Md, University Of Belgrade Faculty Of Medicine.

Gimnasium Of Karlovac, High School