Ella Helgeman Mscee, Mba,Raps,Team Prrc Email & Phone Number

Malmö, Se

Rockville, Md, Us

Copenhagen, Dk

Member of the Senior Management team, reporting to CEO. Lead all Regulatory Affairs and Quality Assurance activities for innovative medical device for migraine treatment, including developing and implementing Regulatory and Quality strategies. Hold the position of Person Responsible for Regulatory Compliance (PRRC) according Article 15 of the Regulation (EU) 2017/745 (MDR) of the European Parliament and the Medical Device Council. Responsible for supplier auditing, evaluation, and approval. Team responsibility for country specific regulatory submissions and compilation of submissions and regulatory authorizations, such as IDEs ,De Novo and CE dossiers for EU, etc. Provide regulatory insight on business matters. Ensure external communication with regulatory bodies.

Fort Myers, Florida, Us

I am Mentor for Regulatory and Quality Affairs at STRIPES Women in MedTech Mentorship Program. My role is to support and guide women MedTech professionals in navigating their careers within this field.Objectives -Career Development: Helping mentees develop skills, set career goals, and create action plans to achieve those goals.-Leadership

Paris, France, Fr

I am Team PRRC representative PRRC for Denmark and Sweden.TEAM-PRRC is the non-profit European Association dedicated to the new profession of "Person responsible for regulatory compliance" (PRRC) which originated in Article 15 of the Regulation (EU) 2017/745 (MDR) and in Article 15 of the Regulation (EU) 2017/746 (IVDR) of the European Parliament and the Medical Device Council.These Regulations specify the requirements of training and/or professional experience necessary to hold the position of PRRC.It is a unique regulatory requirement that applies only within the European Union (EU). The Association represent and help PRRCs to more confidently assume this new profession which has considerable responsibilities in the design, manufacture and supply of medical devices and in vitro diagnostic devices.

Responsible for Regulatory Affairs, Quality Assurance and Clinical Affairs for innovative Class III Implantable medical devices. Leading regulatory, quality, and clinical team to support regulatory, quality and clinical activities for the innovative product portfolio and to promote product innovation. Hold the position of Person Responsible for Regulatory Compliance (PRRC) according Article 15 of the Regulation (EU) 2017/745 (MDR) of the European Parliament and the Medical Device Council. Deliver strategic leadership in leading regulatory affairs department with extensive knowledge of regulatory requirements for federal agencies, such as the FDA. Oversee preparation of PMA, Devise and implement all quality-related practices, programs, and strategies for Quality Affairs Department through line management. Research, develop, and execute effective regulatory strategies for various products. Responsible for Clinical strategy including clinician evaluation and clinical investigation for new technology medical devices.Achievements ● Development of Regulatory Strategy including appropriate regulatory pathway - PMA in the United States, CE marking in Europe), the timing of submissions, interactions with regulatory authorities, clinical trial requirements, quality assurance and compliance measures, and post-market surveillance to ensure ongoing compliance and product safety. ● Development of Clinical Strategy as a strategic plan that outlines how to conduct clinical trials and perform clinical literature search so to gather relevant data to demonstrate the safety and efficacy of our device, ensuring regulatory approval and successful market entry. ● Created and executed a comprehensive Quality Management System aligned with MDR 2017/745, 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304, and other relevant regulations and guidelines.

Member of Intertek Medical Notified Body Senior management team and support of technical experts with the interpretation of regulatory requirements.Represent Intertek Medical Notified Body in relevant regulatory committees and conferencesCo-Chair of the MD Notified Bodies Coordination Group (NBCG-MED)Line management of Regulatory, Quality and Competency and Training teamsOverall responsible and owner of the Notified Body Medical processes including Quality Manual, Non Conformity and CAPA handling, Audit and Inspections, Training and Competency,Responsible for the annual Quality Management Review for Notified Body, Medical including timely follow up on and closure of actionsAchievements ● Achieved success in driving a three cross-functional teams: Regulatory Team, Quality Team and Training and Competence Team in leading the leader setup ● Achieved successful Intertek Medical Notified Body MDR designation as Notified Body main responsible person for Regulatory and Quality, Intertek Medical Notified Body AB (IMNB AB), Notified Body Number NB 2862. ● Held positions of Co-Chair of NBTG Group (Notified Body Technical Group) on the European level and active participation in Team NB Group activities ( Chair of different Working Groups) ● Key speaker at global Regulatory congresses and conference events ● Designed and implemented Quality Management System (QMS) to operate the Notified body. ● Updated QMS to reflect standardization activities, legislation, guidance, and best practice documents, including activities of relevant notified body coordination groups.

Sprimont, Région Wallonne, Be

I was a Chair of few Team NB Working groups and Co-Chair of NBTG Group (Notified Body Technical Group) .Active involvement and support on the implementation of the new Medical Device Regulation and the In-Vitor-Diagnostic Regulation, e.g. by supporting the creation and pragmatic update of MDCG guidances.TEAM -NB is The European Association Medical devices of Notified Bodies, is being formed on 2001.Today the association has 43 members. Those 43 members represent 20 different countries.This association promotes high standards and protects the interests of Notified Bodies.

Copenhagen, Copenhagen, Dk

• Global Regulatory Team •Lead Auditor performing internal audits ( ISO 13485:2016, MDSAP etc)• Preparation for CE marking and 510k submission• MDR readiness for Quality Management system and Product Technical Files• Involvement in all phases of the product development life cycle. • Risk Management process• Process improvements based on audit findings or internal need for improvement• The products cover high quality X-Ray scanner and 3D CAD/CAM software within the Dental and Hearing Aid. Managed MDR implementation in QMS and relevant Technical files for transition from MDD to MDR ● Conducted successfully internal audits to verify compliance with MDR and address any non-compliance issues and reduced number of NCs from Notified Body ● Delivered regulatory guidance to product development teams and spearheaded strategic regulatory implementation through effective design controls during product development process ● Successful preparations and submissions of FDA PMA and 510(k) and international submissions ● Implemented Risk Management , Clinical , Post Market Surveillance and Vigilance processes and procedures in compliance with MDRAchievements ● Managed MDR implementation in QMS and relevant Technical files for transition from MDD to MDR ● Conducted successfully internal audits to verify compliance with MDR and address any non-compliance issues and reduced number of NCs from Notified Body ● Delivered regulatory guidance to product development teams and spearheaded strategic regulatory implementation through effective design controls during product development process ● Successful preparations and submissions of FDA PMA and 510(k) and international submissions ● Implemented Risk Management , Clinical , Post Market Surveillance and Vigilance processes and procedures in compliance with MDR

Darmstadt, Hessen, De

Responsible of following and implementing Quality Management system ( QMS) in development projects for drug delivery products ( medical devices and combination products) aiming US and international markets •Preparation for CE marking and 510k submissions •Ensuring Regulatory compliance •Technical Files and DHF reviews • Ensuring compliance of design control and maintenance processes to applicable regulations/ standards • Establishes Quality Plans in development projects related to product design and development and transfer to production. • Monitors execution of the Quality plan and quality metrics. • Design Review Meetings ( Gate meetings) execution in order to proceed to next development stage of the project • Reviews and approves Verification and Validation Master Plan and V&V Traceability Matrix ( matrix between design inputs and design outputs as verification and between user needs and design validation activities), Design input requirements, V&V protocols and reports. • Preparation of DHF ( Design History Files) and Technical files and regulatory submission files to ensure timely approval of devices worldwide, especially in US • Participation in notified body audits and health authorities inspections • Participation and preparation for Management review meetings and act on actions taken from management review meetings • Participation in supplier quality audits – Quality System and Manufacturing • Performing internal audits for the purpose of Quality Management system updates and improvements

Ballerup, Denmark, Dk

• Initiate and drive Improvement Projects for the products on the market ( lifecycle) which are to be launched as improved version of existing products • Develop project charters, timelines, and work plans; facilitate cross-disciplinary team meetings; ensure that project deliverables are met on time• Identify and pre-empt barriers to project success; manage internal stakeholders to meet project deliverables and provide leadership with updates.• Project Management of ` Market Support Tool’ which is global complaint and CAPA tracking tool • CAPA and/or Deviation Management• Stakeholder in Design Review meetings• Stakeholder in Design Control Process improvements efforts • Work on procedures, for example corporate complaint and CAPA procedure • Providing support during inspections by regulatory bodies, ensure appropriate and timely global medical device reporting, and monitor for trends in product complaints. • Create and monitor KPIs to measure the effectiveness of Postmarket Surveillance activities• Define Early Warning Process ( EWP) which is a global process of early product performance in US markets, Asian markets and UK market• Participation in CAPA Board meetings, Trend Review and other R&D and Quality meetings.

Premstaetten, At

• Planed, deployed, and led lean activities thoughproductivity, quality and improving business processes.• Shown ability to generate results through thoughtful process change and thoroughly leading people to deliver sustained results.• Create and communicate project reports to management to provide visibility for the lean initiative.Management of design and development projects

Geneva, Switzerland, Ch

Team Leadership of 10 Supplier Quality Engineers recruitment, training and performance appraisal Implemented NPI quality requirements for GPU substrate, assembly technology qualifications with cross-function teams, conducted new supplier technical assessments and on-site audits with executive qualification reports• Led efforts in tracking key supplier quality performances with weekly dashboard data review•Developed quality management matrix and the best practices at global quality council, SQE and CQE guidelines and policies to suppliers / customers at corporate quality level• Implemented PPAP (Production Part Approval Process) documentations with BU programmanagers for Handheld customers and MTQ (Manufacturing, Testing and Quality)

Geneva, Switzerland, Ch

Implemented Six Sigma and reliability projects (DOE, manufacturing data correlation, MSL) • Accomplished PSO/PPAP (CP, DFMEA, PFMEA, MSA, APQP) submissions and PPAPcertifications

Geneva, Switzerland, Ch

Test and Product Engineer• Team Leadership: recruitment, training and education of the technicians within the team ensuring a productive environment which adheres to the quality management system• Characterizing failures, determining the suspect corruption and marginal defect inside ASIC/SOC chips, identifying whether production coverage exists for the electrical failure signature identified, check/confirm the pre-screen test coverage of the ASIC/SOC on supplier's testers• Develop hardware and software for characterization and cost effective probe and final test• Correlate ATE to bench measurements

Mba, Management And Business Administration Certificate

Master Of Science (Mscs) In Electronics Engineering

Effective Company Directorship - Rätt Fokus I Styrelsearbetet Sme