Bernard Ismael Email & Phone Number

Paris, Fr

Paris, Fr

As the quality management representative, I have the responsibility and authority to define, implement, and ensure the execution and maintenance of the quality system. Knowledgeable in the procedures and records that support assigned activities throughout the product life cycle, I am the subject matter expert during audits and inspections. With my team of specialists and managers, I ensure that awareness of applicable worldwide regulatory and quality management system requirements is promoted throughout the company.Based on obligations relating to medical devices and radiation protection, I assume the responsibilities and authorities of person responsible for regulatory compliance and as such I monitor the execution of the regulatory strategy for obtaining and maintaining marketing authorizations for medical devices developed and marketed by the company.I represent the company to health authorities and professional organizations, and I additionally verify the compliance of promotional and product information documents. As the vigilance officer, I manage incidents by analysing and following up on the resolution of critical problems, reporting to the authorities and following up on any product safety action.Finally, I act as the company compliance officer, notably by ensuring the company is committed to conducting its business affairs ethically and lawfully.Key Achievements:• I completely revamped the company quality system for harmonization, better synergy between the business units and improved efficiency.• I successfully obtained MDSAP and ISO 13485:2016 certification and paved the way for Regulation (EU) 2017/745.• I led the team towards greater autonomy in understanding and implementing US requirements driving ultimately to shorter and cost-effective FDA clearances.• I revised the Code of conduct in alignment with COCIR and MEDTECH codes.• I significantly improved the digitisation of documentation.

Marlborough, Ma, Us

As the Subject Matter Expert, I led the oversight and integrity of the Corrective Action and Preventive Action, Field Safety Corrective Actions and Acquisition processes across International region (all countries but USA). I maintained the harmonized CAPA process whilst maintaining the integrity of all Quality Systems. I ensured conformity to established standards, Regulatory and Corporate requirements; reviewed, analyzed and reported on any issues/emerging issues including non-conformities. I finally provided input into the Management Review process.My role also acted as a liaison between International and Corporate stewards, regional quality system managers and local/regional process Mentors/Coordinators around the world to foster compliance within BSC.I led the quality system integration of new acquisitions for International, in coordination with the global Integration Project Leads. As such, I acted as the first point of contact for International Quality and liaised with the Integration teams and Regional/Country contacts to ensure launch of new products was compliant with quality system requirements.Key Achievements• As Problem Solving expert, I conducted Lean Business projects on CAPA and Field Action processes.• I effectively led and managed a team of up to 5 regulatory specialists and took leadership of cross-functional project teams hosting weekly community calls with local units or being facilitator of engaged and productive practitioner communities.• At all times, I highly improved the department visibility within large company organizations.

Marlborough, Ma, Us

As a Complaint and Vigilance expert, I identified opportunities involving Europe, Middle East and Africa countries and business units and proposed and implemented solutions to optimize Post Market operations (complaints, vigilance and customer responses) while ensuring adequate information flow within the region.Key Achievements:• I reached 70% of complaints reported in less than 48h for my organization.• I led 3-day training sessions on complaint handling.

Lisses, Île-De-France, Fr

Reporting to the Quality Director, I managed the regulatory affairs department and my main goal was to provide regulatory pathways via agencies and authorities in order to achieve worldwide marketing clearance for the company in-vitro diagnostics products.Key Achievements:• I represented the company in EDMA taskforces.

Minneapolis, Mn, Us

Within the Regulatory Affairs Europe department and in strong relation with the Emerging Markets organisation, I developed, managed and implemented policies, procedures and a system to monitor and supervise all regulatory activities in interaction with local regulatory functions for all the Business Units in Eastern Europe, Central Asia, Middle East, Africa and South Asia.Key Missions• Development of regulatory strategies, plans & requirements lists and preparation of submissions as required to ensure appropriate and timely market release• Interface with multiple functional areas, geographies and divisions across various modalities within the company• Provision of on-going support to local sales organisations for regulatory issues and questions• Development and influence of government and regulatory policy in support of company’s objectivesKey Achievements:• I anticipated emerging regulations in India, Turkey and South Africa and participated to successful integration of acquired companies within mother company quality system.• In several instances, I negotiated with officials in India or in the USA and promoted creation of local trade associations.• I issued periodical newsletters & country guidance.• I represented the company in EUCOMED, or ADVAMED taskforces.

Irvine, California, Us

Within the R&D Direction of urological and surgical division (former Porgès), I supervised the Regulatory Affairs team, owned and implemented the Regulatory Affairs procedures and processes to ensure products meet worldwide regulatory requirements through development, market clearance, and post marketing phases. Key Missions• Creation and maintenance of Technical Files for compliance with the EU Medical Device Directive (93/42/EEC) and other worldwide regulations• Risk Management supervision within project teams including R&D, Medical/Clinical and Marketing in alignment with ISO 14971 requirements• Biocompatibility evaluation accordingly to ISO 10993 standards• Liaison with LNE / G-Med (French notified body) and AFSSaPS (French competent authority, now ANSM)• Company representation in SNITEM and APPAMED (2 French trade associations)• Provision to the business of consultative expertise, guidance and promotion of compliance with laws, regulations & standards• Standard and regulation surveillance• Direct supervision of 2 Regulatory Affairs Specialists and indirectly of 3 Documentation SpecialistsKey Achievements• I handled CE Marking compliance for 40 families of products (class I, IIa, IIb)• I experienced four successful 510(k) submissions with FDA (K013172, K013174, K013921, K021856)• I registered 90% of products in 14 months in Canada and divided by half the submission cycle time in Japan• I obtained reimbursement with French authorities for Macroplastique, an injectable soft-tissue urethral bulking agent for treating stress urinary incontinence (a Uroplasty product)• I ensured effective and rapid transition from EN 1441 Medical Devices - Risk Analysis to ISO 14971 Application of risk management to medical devices• I reorganized classification of standards for the company

Paris, France, Fr

Within Porgès division and reporting to the R&D Director, I led the technical product development of urological instrumentation & devices and provided support on all mechanical engineering aspects of the existing product range.Key Missions• Close work with other team members (clinical, production) and stakeholders (marketing, surgeons) in all areas of product development, including needs and requirement analysis, understanding of new surgical techniques, planning, prototyping, product design, and testing• Provision of technical support to the Purchasing department including sourcing, negotiation, review and approbation of sample deliveries from potential suppliers• Active participation to the implementation of Quality Certification (ISO 13485) and CE marking (93/42/EEC)Key Achievements• I increased the nephrostomy product portfolio by 65% and developed a test procedure database.• I submitted 2 patents: - EP 0 872 259 for a flexible chirurgical drain with a plurality of individual ducts and; - EP 0 935 974 for a telescopic device to dilate a body vessel.• In a view to improve the quality of our outsourced items, I drew up quality charters and product specifications with our suppliers and took part in external foreign audits.

European Master Degree (Dea), Bio-Mechanics

Master Of Engineering Degree, Mechanics