Quality Assurance and Regulatory Affairs in Medical Device Industry (MedTech)
FJ
Open to opportunities
Faizan Javed
@faizanjaved2
Head of QARA at Byonyks Medical Devices, where I secured FDA 510(k) clearance and built an ISO 13485-certified QMS.
PakistanWhat I'm looking for
At Byonyks Medical Devices, I led the FDA 510(k) submission for a Class II Automated Peritoneal Dialysis Cycler and helped secure clearance one month ahead of schedule. I also designed and implemented a QMS from zero, achieving ISO 13485 certification within three months.
I architected and validated an eQMS using Surround SCM and Helix ALM, and integrated risk management into design methodologies. I also led usability studies and authored the APD Cycler Instructions for Use, including animations that reduced user errors by 95% in human factors testing.
Alongside my role at Byonyks, I provide QARA input to eForte’s AI-driven compliance platform and take on independent audit, training, and documentation engagements. I’m a CQI & IRCA Certified ISO 13485:2016 Lead Auditor.
Experience
Work history, roles, and key accomplishments
EF
Current
QARA Consultant
eForte
May 2026 - Present (5 months)
Ongoing part-time engagement providing regulatory and quality-systems input on an AI-driven compliance platform for MedTech companies.
BD
Current
Head of QARA
Byonyks Medical Devices
Jan 2021 - Present (5 years 9 months)
Directing a 15-person QARA team across all QARA functions. Led FDA 510(k) clearance, built QMS to ISO 13485, and architected eQMS.
PS
Speaker, Beyond Compliance
PrimeCert Regulatory Services
Aug 2026 - Aug 2026 (0 months)
Spoke at a webinar on the future of global regulatory affairs and quality.
DA
Independent ISO 13485 Audit
DandleLION
Oct 2025 - Oct 2025 (0 months)
Conducted a third-party ISO 13485 audit of a prospective Pakistan-based supplier for a US company, informing their go/no-go decision.
BI
Design & Development / Risk Management Training
BioCentrica
Sep 2025 - Sep 2025 (0 months)
Delivered training on design and development processes and risk management for medical devices.
JH
User Manual Development
Jardin Home Health
Aug 2025 - Aug 2025 (0 months)
Designed and authored a user manual for a US home health client.
QU
CSA, CSV & Data Integrity Training
Qualtivate
Mar 2025 - Present (1 year 7 months)
Co-developed and delivered training presentations on software validation and data integrity for industry audiences.
Education
Degrees, certifications, and relevant coursework
National University of Sciences and Technology
Master of Science, Design & Manufacturing Engineering
2020 - 2023
Pursued a Master of Science in Design & Manufacturing Engineering, focusing on advanced manufacturing and design principles.
Pakistan Institute of Engineering & Applied Sciences
Bachelor of Science, Mechanical Engineering
2016 - 2020
Earned a Bachelor of Science in Mechanical Engineering, covering core mechanical engineering topics and applications.
Availability
Open to opportunities
Location
PakistanAuthorized to work in
Salary expectations
60k-80k USD
Social media
Job categories
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