Regulatory Affairs Consultant
Fully Remote
3-6 Months Hourly Rate
Qualifications/Skills
Experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements (on this occasion someone with at least 60% CMC and 40% Device) and a fast learner.
Below a very top-level list (can provide detailed list later).
* Bachelor’s Degree (or higher) in a relevant scientific or engineering field.
* Experience in regulatory affairs within the medical device, CMC or Drug-Device combination product industry, preferably from pharmaceutical industry or from a regulatory agency.
* Demonstrated understanding of and ability to interpret regulations and guidelines governing pharmaceutical products and medical devices.
* Strong knowledge of regulatory submission processes and global regulatory frameworks.
Focused work for Q1 2025:
* Regulatory support to O1 Device Development (DD) team and activities e.g. final review, comment and approval of existing device-related technical documentation including device verification and validation documents, device specifications, risk management, human factors, biological evaluation, device labelling, IFU/QRG, End of Phase review and advising on interpretation of legislation/guidance, attending internal device development meetings.
* Regulatory CMC support to Pharmaceutical Development (PD) team e.g. final review, comment and approval ...