freelancer
Email Verified Angela S
0.0/5 (0 Feedback)
Member since March 26, 2019

CE Mark for your Medical Device

  • $95.00 - $150.00 / hr
  • //medlance.co/wp-content/uploads/2020/06/american-flag-emoji-by-google.pngUnited States
  • Save

Do you understand the new Medical Device Regulations in Europe? I can help to gain your CE mark. I have over 20 years of experience in the regulatory industry in Europe.

Medical writing, consulting, clinical evaluation reports (CER), clinical study reports, US FDA and EU regulatory submissions for Class I, II & III medical devices, PMAs, 510(k)s, CE marking, PSUR, SSED, SSCP, risk-benefit analysis, clinical evaluations, performance evaluation reports (PER), publications, clinical & regulatory strategy, project management, regulatory agency responses, EU MDR, EU IVDR, MEDDEV 2.7/1 revision 4

Therapeutic areas of expertise: molecular diagnostics, diabetes, cardiology, otorhinolaryngology, ophthalmology, orthopedics

Services

Service
  • 0.0/5 (0)
  • 0 in Queue

Experience

Regulatory Specialist

  •  Amento Tech
  •  Aug 2018 - Present

“ Consectetur adipisicing elit sed do eiusmod tempor incididunt ut labore et dolore magna aliquaenim ad minim veniamac quis nostrud exercitation ullamco laboris. ”

Regulatory Manager

  •  Mtech Startup
  •  Jun 2017 - Jun 2018

“ Consectetur adipisicing elit sed do eiusmod tempor incididunt ut labore et dolore magna aliquaenim ad minim veniamac quis nostrud exercitation ullamco laboris. ”

Regulatory Consultant

  •  Medtronic
  •  Sep 2017 - Sep 2016

Consectetur adipisicing elit sed do eiusmod tempor incididunt ut labore et dolore magna aliquaenim ad minim veniamac quis nostrud exercitation ullamco laboris.

Education

Web & Apps Project Manager

  •  Amento Tech

Consectetur adipisicing elit sed do eiusmod tempor incididunt ut labore et dolore magna aliquaenim ad minim veniamac quis nostrud exercitation ullamco laboris.

Sr. PHP & Laravel Developer

  •  Amento Tech
  •  Apr 2016 - Apr 2017

Consectetur adipisicing elit sed do eiusmod tempor incididunt ut labore et dolore magna aliquaenim ad minim veniamac quis nostrud exercitation ullamco laboris.

PHP Developer

  •  Amento Tech
  •  Apr 2016 - Apr 2017

Consectetur adipisicing elit sed do eiusmod tempor incididunt ut labore et dolore magna aliquaenim ad minim veniamac quis nostrud exercitation ullamco laboris.