Arun M.

Regulation professional with 16+ years experience in Medical Devices

United Kingdom
English

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 Healthcare
3 years
Current position
Aug 2020 - Present
Pennine 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 Ltd
2 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

ConvaTec
4 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

Microvisk
1 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

Microvisk
2 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 Ltd
2 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 Trust
1 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