Domestic (US), EU, Canada, LatAm, and Asia device registrations, medical device submissions, technical documentation review, and auditing.Technical document preparation and supplier auditing (ISO 22442) for heparin coating on Class III devices.QSR, MDR, MDSAP, ISO compliance.

Achievements / Responsibilities:Regulatory Affairs:- PMA P100016; 510k K123888; several IDEs- FDA and CE Quality Management Systems; cGMP- Corporate strategy (regulatory)- Submissions and annual reports- Technical files; design dossiersQuality Systems Management; ISO 13485, 21 CFR 820, 9001- Complaint handling; post-market surveillance- Document control- CAPA; Non-conforming products; Calibration- Auditing - internal and external (key suppliers)- Sterility: EO, moist heat- Management Rep; official correspondent; management review (2 sites)Registrations, labeling and Own Brand:- CE-Marking- Private label business models- International registrationsClinical Affairs, GCP:- Clinical investigation of medical devices- Clinical site initiation, monitoring, closeout- US and OUS investigators- Informed consent, case report form & protocol development- CROs, IRBs, Ethics oversight- Annual reports- IDE pre-clinical testing- Literature review and risk analysisAnimal Origin (AO) Products (ISO 22442):- Combination devices (Drug-Device); application of AO products to devices- Competent Authority consultations- Supplier auditsRisk Management; Design Control:- Design control; product development process- ISO 14971; application of risk management- Device safety and benefit analysisBusiness Management and Leadership:- Process improvement; Project management- Mentoring for individual and group excellence- Leadership training and development- Cross-functional operations and teams- Budgeting Personal Traits:- Exceptional attention to detail- Hybrid regulatory, quality systems & operations expertise- Superb verbal and written communication skills - Collaborative, highly ethical- Systems and process oriented Interests:- Continuous improvement- Lean manufacturing- Innovation and adding value- Business modeling and reinvention- Operations and regulatory strategy- Uncontested, emerging markets- Human trials; product performance

Medical Device Quality Systems ManagementRegulatory Affairs:- FDA and CE Quality Management Systems- Submissions and annual reports- Technical files; design dossiersQuality Systems Management; ISO 13485, 21 CFR 820- Complaint handling; post-market surveillance- Document control- CAPA; Non-conforming products; Calibration- Auditing - internal and external (key suppliers)- Sterility: EO, moist heat- Management Rep; official correspondent; management reviewAnimal Origin (AO) Products (ISO 22442):- Combination devices (Drug-Device); application of AO products to devices- Competent Authority consultations- Supplier auditsRisk Management; Design Control:- Design control; product development process- ISO 14971; application of risk management- Device safety and benefit analysisBusiness Management and Leadership:- Process improvement; Project management- Leadership training and development- Cross-functional operations and teams- Budgeting

Operations management; multiple shifts; medical devicessMolding, finishing, assembly, primary packagingSupply chain optimizationCreating value; Lean manufacturing conceptsTraining for compliance and excellenceSOP creationSafety Committee