Senior Regulatory Affairs Lead — Medical Devices (Global Scope)

OrganOx Limited; Oxford; Presencial; GBP 75.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare

Retirement plans

Professional development

Work-life balance support

Descripción de la vacante

OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for its metra platform and related projects. The role focuses on developing regulatory strategies, preparing submissions, and ensuring compliance across markets, including outside the US.

It requires collaboration with Manufacturing, Quality, R&D, and Clinical teams in a fast-paced environment. The candidate will coordinate with regulatory authorities, manage lifecycle submissions, and support change

Formación

• Strong regulatory affairs experience in the medical device industry.
• Experience with submissions in US, EU, and other jurisdictions.
• Willingness to travel up to 5% domestically and internationally.

Responsabilidades

• Lead and support pre-/post-market regulatory activities for devices and changes.
• Assess regulatory impact for design, labeling, packaging, supplier and manufacturing changes.
• Develop regulatory strategies for new products and renewals across markets.
• Coordinate with regulators: drafting letters, tracking submissions, responding to information requests.
• Partner with teams to define regulatory requirements and align development with expectations.
• Review validation, risk management, and change documentation for regulatory support.
• Contribute to process improvements, regulatory intelligence, and internal tools.
• Provide training and support to department members.
• Comply with OrganOx Code of Conduct and policies.
• Engage with authorities to support submissions and inquiries throughout lifecycle.

Conocimientos

Regulatory affairs

Regulatory knowledge

Technical writing

Cross-functional collaboration

Regulatory authority engagement

Educación

Bachelor’s degree in technical discipline

Descripción del empleo

OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for its metra platform and related projects. The role focuses on developing regulatory strategies, preparing submissions, and ensuring compliance across markets, including outside the US.

It requires collaboration with Manufacturing, Quality, R&D, and Clinical teams in a fast-paced environment. The candidate will coordinate with regulatory authorities, manage lifecycle submissions, and support change