Leader for Regulatory Programs for Combination Products

Remote Technology Sweden AB

Okänd ort

Previous experience is desired

~45 000 kr / per month ->
Fixed monthly, weekly, or hourly salary

Education: Hälso- och sjukvård
Eftergymnasial utbildning två år eller längre

Published 2025-03-20 Permanent employment Full time

9 days left
to apply for the job

Lead regulatory programs for combination drug-device products in the US, UK, and EU, with a focus on securing MHRA approval for a first combination product. Requires expertise in regulatory submissions, quality standards, and clinical evaluation, particularly in nicotine replacement therapy (NRT). Oversee device approvals, including Conformity Assessment (CA) and CE/UKCA marking. Lead internal teams and external partners (CROs, Notified Bodies). Ensure compliance with UK MDR 2002, ISO 13485, GMP, ISO 14971, and human factors standards. Manage post-market surveillance and stay updated on regulatory changes.