Marc Bergenthal Email and Phone Number

• Concentrate on product submissions (e.g., FDA 510(k) or CE marking) and development of regulatory strategies, along with technical documentation (e.g., STED or EU MDR) and risk management according to ISO 14971.• Engage in a number of technical objectives, including software development according to EN 62304 and EN 82304-1, artificial intelligence (AI), machine learning (ML), Software as a Medical Device (SaMD), Software as a Service (SaaS), and cloud and mobile devices.• Optimize processes and interfaces across the Quality Management System (QMS).• Fulfill document and record control using Good Documentation Practice.• Conduct internal and external audits such as EU MDR, MDSAP, or FDA inspections featuring a front room/back room setup.• Execute supplier audits and management duties.• Take corrective and preventive actions (CAPA).• Contribute to QMS and product remediation, as well as (SW) tool and process validation.• Oversee administration of complaint handling and vigilance, field actions and recalls, and non-conformities.• Function as a Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).• Deliver project support and planning solutions.• Enact standards management and related duties.

• Provide leadership, own processes, and oversee functions of the RA team.• Function as Person Responsible for Regulatory Compliance (PRRC), and acting as the proxy for the Head of QM/RA and QMR (QMB).• Facilitate development projects by providing regulatory guidance during all design control phases of the product lifecycle.• Accountable for coordinating, monitoring, and submitting regulatory submissions such as US FDA 510(k)s or Technical Documentation acc. EU MDR.• Direct operations for both the back and front office during audits and inspections.• Host training opportunities for colleagues on regulatory requirements and internal procedures.• Supervise, review, and implement regulatory requirements on a global scale.• Administer and support cross-functional teams in other areas like CAPA, Risk Management, Complaint Handling, Vigilance/MDR, Field Actions and Recalls, Clinical Evaluation and Investigation, and Post-Market Surveillance.• Introduce new software tools and solutions that improve current systems.• Participate in and support software validation efforts.Achievements• Responsible for remediating and restructuring the RA department and significantly improving internal and external audit results.• Synchronized and consolidated local processes with corporate QMS.• Attained EU MDR certification ahead of project plan.

• Governed and took responsibility for the QM team (including CAPA, complaint management, MDR and vigilance, KPI reporting, internal/external audits, and document control), along with acting as the proxy for Head of QM/RA and QMR (QMB).• Managed both back and front office during audits and inspections.• Educated colleagues on regulatory requirements and internal procedures.• Ascertained timely KPI reporting, both internally and on the corporate level.• Monitored and implemented corporate guidelines and procedures, as well as EU MDR requirements.• Spearheaded process optimization work groups.• Introduced new software tools that resulted in improvements to current systems.• Performed and supported software validation objectives.Achievements• Minimized open complaints via process optimization.• Revitalized the document control process while concurrently improving efficiency and acceptability.• Ensured MDSAP compliance and readiness.• Devised a US-focused regulatory strategy for the product portfolio, reducing lead time and risks, as well as successfully submitting three 510(k) submissions.• Performed change of notified body.

• Charged with managing medical and non-medical software (class C acc. IEC 62304) and electrical products, including wireless communication and (non-)sterile, disposable, and reusable instruments or accessories.• Provided comprehensive review of technical files and design dossiers before CE marking a new or changed product.• Assessed product design changes and supported implementation.• Originated global regulatory strategies in collaboration with subsidiaries, and compiled regulatory submissions.• Adapted quality system to changing regulatory requirements.• Carried out internal audits and participated in regulatory agency audits.• Took responsibility for the back office during FDA inspections.• Instructed employees on regulatory requirements and functioned as contact point for apprentices.• Owned standards management processes, and served as the proxy for Manager Regulatory Affairs.Achievements• Augmented regulatory strategy and software development processes considering IEC 62304.