Arun M.
Regulation professional with 16+ years experience in Medical Devices
Knowledge and Experience in; Design & Development, 3D CAD skills (SolidWorks), Regulatory affairs (CE, FDA 510K clearance, Health Canada), Clinical Evaluation, Software Medical Device, SaMD, Project m...see more
- Biotech, Pharma & Life Sciences
- Biotech, Pharma & Life Sciences
- Risk & Compliance
€450
/hr
- Pre-vetted expert
- Confirmed hourly rate
- Available on short notice
Experience
Head of Regulatory Affairs
Pennine Healthcare3 years
Current position
Aug 2020 - PresentPennine Healthcare is a family owned business specialising in the manufacture of sterile products used in custom procedure packs for anaesthetic, respiratory, gastroenterology, urology ...see more
Regulatory Affairs Manager
Vision RT Ltd2 years
Apr 2018 - Jul 2020
Hands on experience in new MDR 2017/745 - class iib devices.
Successfully led MDR QMS and Techical documentation audit.
New PMS and PMCF requirements and MDR Gap analysis.
Clinical Eva...see more
Regulatory Affairs Specialist
ConvaTec4 years
Sep 2013 - Mar 2018
Experience in Class I, IIa, IIb and III medical devices. MDD 93/42/EEC, ISO 13485
Devices with medicinal substance/animal derived material.
STED/Technical Documentation for Class I, IIa...see more
Quality and Regulatory Affairs Officer
Microvisk1 year
Feb 2012 - Aug 2013
In-Vitro Diagnostic Medical Device
Prepare regulatory documents (technical file) required for EU submission.
Review Verification and Validation protocol (hardware and software).
Meet th...see more
Product Development (Instrumentation) - IVD
Microvisk2 years
Mar 2010 - Feb 2012
IVD Instrument design & development
Design control documents
Design History File
Device Master Record
Regulatory compliance
Research and Product Development Engineer
Renishaw Advanced Materials - Diameter Ltd2 years
Sep 2007 - Feb 2010
Medical Device based Activity
Design and development of gastrointestinal surgical device.
Conceptual design, 3D engineering drawings and Prototype development.
Special reference to biom...see more
Researcher
The Hillingdon Hospital NHS Trust1 year
Sep 2006 - Sep 2007
Collaboration with Brunel University for prototype development (medical Device)
Industries, roles and expertise
Industry experience
- Biotech, Pharma & Life Sciences
- Biotech, Pharma & Life Sciences
Role experience
- Risk & Compliance