Director of Regulatory Strategy

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.