Alina Mocanu
Consulente @Biochem Consulting
Signup · Get unlimited contacts
WORK HISTORY
Consulente @Biochem Consulting
Napoli, IT
Key Responsibilities – Regulatory Affairs & Quality Assurance ConsultantSupport clients in the design, implementation, and optimization of Quality Management Systems (QMS) compliant with ISO 9001 and ISO 13485, ensuring adherence to applicable regulations and standards.Provide expert guidance on quality-related activities, including drafting and updating QMS documentation, preparation for internal/external audits, management of CAPA processes, and development of customized training programs for staff.Act as a strategic advisor to foster a culture of quality within client organizations, helping different departments translate regulatory and normative requirements into practical, efficient, and compliant processes.Ensure product compliance with Directive 93/42/EEC and Regulation (EU) 2017/745 (MDR), assisting clients in product classification, CE marking strategy, preparation and review of technical documentation, and drafting of declarations of conformity.Monitor evolving regulatory requirements, advising clients on necessary updates to procedures, documentation, and product lifecycle activities to maintain ongoing compliance.Provide oversight and support in Quality Control processes (Incoming, In-Process, and Final QC), including calibration management, non conformity handling, and root cause analysis.Manage interactions on behalf of clients with notified bodies, certification entities, and competent authorities, facilitating communication, submissions, and regulatory approvals.Promote continuous improvement initiatives by recommending best practices, process optimization, and risk-based approaches to maintain the highest quality and compliance standards.
EDUCATION
Colegiul "Gheorghe Munteanu Murgoci"
High School Diploma
University of Bucharest
Master's degree
Universitatea din București
Bachelor's degree
SKILLS
ABOUT ALINA MOCANU
With over 11 years of experience in the medical device industry, I have developed a comprehensive skill set that spans all aspects of medical device design, validation, and on-site application. Throughout my career, I have demonstrated a precise approach to managing projects and a steadfast commitment to excellence in every task. My expertise includes proficiency in product development, customer training, and hands-on problem-solving, with a strong ability to identify and mitigate potential issues before they impact project timelines or product quality. In my current role as a Quality Assurance & Regulatory Affairs Manager, I have embraced a new opportunity to expand my knowledge and deepen my expertise in compliance, regulatory submissions, and quality systems management. This role has enriched my perspective, reinforcing my commitment to continuous learning and operational excellence. Overall, my extensive experience combined with a precise and dedicated work ethic positions me as a valuable contributor to the success of any organization.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.