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Summary
This expert consultant is a trusted, authentic technical project management leader who has diversified experience in managing from small to large complex projects and hand-on experience / expertise in various areas within associated activities. The span of his experience includes various stages of new product development life cycle to product commercialization and follow ups through post market surveillance. This life science r&d project management expert also worked on numerous FDA 483 observations and helped client’s in achieving quality and compliance targets. He has a unique balance of technical, operational and financial savvy and has built a track record of identifying opportunity, and delivering differentiated products that catalyze profitable growth. This life science expert has a strong understanding of regulatory requirements and standards applicable to medical devices, such as FDA regulations 21 CFR Part 820, ISO
13485:2016, ISO 14971:2019, ISO 10993, 62304:2006.
Highlights
- Product Development Project Management / Design Control
- Corrective and Preventive Actions (CAPA)
- Quality Management System (QMS) – ISO 13485:2016 Quality Improvements (6 Sigma Certified)
- Risk Management (ISO 14971:2019)
- Supplier Management
Relevant Accomplishments
- Project managed the transition of legacy products from MDD to EU MDR and met EU MDR 2014/745
requirements. He worked with cross functional teams, coordinated with program subsystem teams and
met project deliverables, synchronization and prioritization of core team activities. - Evaluated impact of new released ISO standards, developed new assessment templates, revised SOP’s and brought back program overall timing by coordinating all development efforts through team ownership and commitment to project milestones.
- Turned around program delays, prioritized team activities, developed project plans and milestones. Brought back program on track and met notified body submission schedules
- Led R&D team and improvements were made in Knee design and development process.
- Led Risk Management / Design Control workstream and reviewed / updated documents as per section 1, 3, 4 and 8 of Annex I of EU-MDR 2014/745. Reviewed design inputs (physical & performance characteristics), user needs, intended use (device- human interface), reviewed DFMEA’s, evaluated risk associated with, and occurring during the intended use and during foreseeable misuse. Set up design
review meetings, reviewed design outputs, design verification data. Managed other Program Managers workstream activities and development of technical files and ensured products met the General Safety and Performance Requirements (GSPR). - Supported corporate quality and compliance initiatives and helped in QMS ISO-13485:2016 implementation across organization and improvement in product development process.
- Cut down on backlog of customer complaints internal inconsistency, and associated CAPA’s. Led engineers and cross functional team members and performed retrospective review and remediation of reportable complaint event files. Identified product issues, developed feedback process and updated
risk documents and improvements in product design.
Roles
- Principal Program Manager Regulatory (Consultant) -Cardinal Health
- Project leader Regulatory (Consultant) – Medtronic
- CAPA Project Manager (Consultant) – Zimmer
- Complaints and Quality Systems Leader (Consultant) – Terumo
- Cardiovascular Project Consultant Supplier Management – Abbott
- Project Leader Complaints and Non-Conformance (Consultant) – COOK
- Project Lead QA/ RA (Consultant) – Biomet 3i
Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
To apply for this job email your details to haleymmagnani@gmail.com
