Senior Regulatory & Quality Lead, EU/UK/CH

BD; Drogheda; In loco; EUR 60.000 - 70.000; Tempo pieno

Descrizione del lavoro

BD is seeking a Senior Quality and Regulatory Affairs Specialist to support the EO Hub across the EU, UK and Switzerland. You will monitor evolving regulatory requirements, conduct impact assessments, and drive compliance activities for Authorised Representatives, Importers and Distributors.

You will collaborate with cross‑functional teams to implement regulatory changes, manage device registrations, and maintain robust quality system documentation.

Competenze

• Experience in regulatory operations within medical devices is preferred.
• Ability to translate regulatory changes into implementation plans.
• Experience supporting device registrations and technical documentation reviews.

Mansioni

• Monitor regulatory developments across EU, UK and Switzerland and communicate requirements to stakeholders.
• Conduct regulatory impact assessments and gap analyses for new regulations.
• Develop and execute compliance implementation plans for regulatory changes.
• Act as regulatory SME for EO requirements and guidance to cross-functional teams.
• Support Authorised Representative activities, tech documentation reviews, and device registrations.
• Maintain and enhance QMS documentation and records.
• Support audits, inspections and regulatory assessments with compliant responses.
• Analyze compliance metrics and drive continuous improvement initiatives.

Conoscenze

Regulatory affairs

EU MDR knowledge

UK/Swiss regulation knowledge

Regulatory submissions

Descrizione del lavoro

BD is seeking a Senior Quality and Regulatory Affairs Specialist to support the EO Hub across the EU, UK and Switzerland. You will monitor evolving regulatory requirements, conduct impact assessments, and drive compliance activities for Authorised Representatives, Importers and Distributors.

You will collaborate with cross‑functional teams to implement regulatory changes, manage device registrations, and maintain robust quality system documentation.