Welcome to my profile! For a more detailed discussion of how I can assist you or your company, please contact me directly.

Brief introduction:

My name is Sarai, I am a qualified medical doctor and regulatory affairs specialist, specialising in medical translation and regulatory writing. I am completing my Masters degree in EU regulatory affairs, specialising in both medicinal products and medical devices. I have already obtained certification from the Regulatory Affairs Professionals Society (Medical Devices).

I predominantly work with international manufacturers and translation agencies offering culturally appropriate, medically accurate translation and medical writing in native English, thanks to the following privileges:

• childhood education in Birmingham, England, United Kingdom
• university education at the prestigious University of Cape Town, South Africa
• experience as a medical exchange student at the oldest, private university in Japan, Nippon Medical School, Tokyo
• 10+ years working as a freelancer in Düsseldorf, Germany

Medical Translation

As a native English speaker, please contact me if you need experienced and expert translation of medical and regulatory documents from the following languages into English suitable for the UK, US or Canadian markets:

Japanese (3,350,000 characters translated to date) 

German (1,103,000 words translated to date)

Dutch (207,000 words translated to date)

I have worked extensively on the following document types for compliance with the strict requirements set by the EMA, notified bodies, FDA, Swissmedic, PMDA and Health Canada:

• Medical Journal Articles
• Case Reports and Dissertations
• CRFs, eCRFs
• Clinical Study Reports
• Pharmacological Studies (Toxicity, Stability, Biocompatibility)
• CTD, eCTD, STED
• Summary of Product Characteristics (both translation and writing)
• Investigator's Brochures (both translation and writing)
• Clinical Trial Applications (both translation and writing)
• Adverse Event Reports
• Medical Brochures and Marketing Materials
• Patient Medical Records (highly confidential)
• Informed Consent Forms (both translation and writing)
• Patient Information Documents (both translation and writing)
• Medical Device Technical Documentation (both translation and writing)
• Questionnaires
• Patient Diaries

For document types not listed here, please request further information directly at [email protected]

Regulatory Writing

You are a busy, high-ranking professional in the lucrative field of life sciences or medical device research and development – otherwise you would not have taken the time to read my profile. You work with demanding clients, with challenging deadlines and extremely precise style and terminology requirements. You are also keenly aware of prevailing, global financial conditions – you understand that the words "added value" represent both a corporate mission and a personal KPI.

    If your strategy is focused on the EU (non-exhaustive list of examples):

• Have your clients expressed or explained the significance of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (Medical Devices Regulation [MDR] and In Vitro Diagnostic Medical Devices Regulation [IVDR], respectively)?
• Do you assist manufacturers to design and conduct clinical evaluations in accordance with the MDR, MEDDEV 2.7/1, and clinical investigations in accordance with the MDR, ISO 14155, MDCG 2021-6, clinical trials in accordance with Regulation (EU) 2017/745 (Clinical Trials Regulation [CTR]), or clinical performance studies in accordance with the IVDR and ISO 20916:2019?
  
• Do your clients undergo inspections in accordance with Good Manufacturing Practice as governed by Regulation No. 1252/2014 and Directive 2003/94/EC?
• Are your clients required to adhere to Good Pharmacovigilance Practice as governed by Regulation (EC) No 726/2004 and Directive 2001/83/EC?
• Are your clients struggling to source appropriate supportive literature to meet the Product Validation and Verification Requirements under the MDR Technical Documentation requirements in Annex XV?

With your in-depth understanding and knowledge of the regulatory landscape within the EU as well as in key economies, such as Switzerland, Japan, the US and the UK, you will specifically benefit from the following:

• my medical degree and continuous professional development in the medical field,
• my 10+ years of experience supporting:

                applications for authorisation/assessment to competent authorities (EMA/notified                 bodies, Swissmedic, FDA, PMDA, Health Canada)

                compiling literature reviews from multilingual source documents (English, Japanese,                 German, Dutch),

                multinational clinical trial submissions and correspondence with ethics                 committees/institutional review boards,

                document preparation and provision for compliance audits and inspections,

                multilingual complaints monitoring, summarising and reporting (English,                     Japanese, German, Dutch),

                SAE, SUSAR and PSUR translation, classification and reporting...

                ... and so much more.

• my 10+ years of experience in independently crafting tailored, native English text for medicinal products and medical devices for submission to the EMA/notified bodies, Swissmedic, FDA, PMDA and Health Canada

                Summary of Product Characteristics (both translation and writing)

                Investigator's Brochures (both translation and writing)

                Clinical Trial Applications (both translation and writing)

                Informed Consent Forms (both translation and writing)

                Patient Information Documents (both translation and writing)

                Medical Device Technical Documentation (both translation and writing)

Please reach out if you would like to receive a copy of my portfolio for your perusal.