Senior Regulatory Lead: Class III MDR Medical Devices

Panda International; Barcelona; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Panda International seeks a senior Regulatory Affairs leader to own EU MDR strategy for Class III devices, including dermal fillers, and to serve as the main liaison with the notified body. You will lead technical documentation, post-market activities, and registrations for new markets as the business grows.

The role requires hands-on authorship and a track record with MDR conformance, risk management, and clinical evaluation.

Qualificações

• 8+ years in medical device Regulatory Affairs, with at least 5 years on Class III or implantable devices.
• Direct, first-hand experience with notified bodies: led a Class III conformity assessment or MDR recertification and handled audit findings.
• Strong working knowledge of EU MDR 2017/745, including Annex XVI, MDCG guidance, clinical evaluation and PMS requirements.
• Hands-on authorship of technical documentation, risk management files and clinical evaluation input.
• Working knowledge of ISO 13485 and ISO 14971 in a manufacturing environment.
• Degree in life sciences, pharmacy, chemistry, biomedical engineering or similar; qualifies as PRRC under MDR Article 15.
• Fluent English; able to defend a regulatory position with auditors and senior management.

Responsabilidades

• Set and run the EU MDR regulatory strategy for Class III and Class IIa devices, including dermal fillers covered by Annex XVI and its common specifications.
• Own the relationship with the notified body: plan and lead conformity assessments, technical documentation reviews, surveillance and unannounced audits, and answer deficiency questions.
• Prepare and maintain technical documentation (Annex II and III), including the GSPR checklist, risk management file (ISO 14971) and labelling and IFU.
• Work with clinical and R&D on clinical evaluation reports, PMCF plans and reports, and the Summary of Safety and Clinical Performance (SSCP).
• Lead post-market surveillance outputs: PSURs, vigilance reporting, field safety corrective actions and trend reporting.
• Act as, or closely support, the Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15.
• Manage EUDAMED registrations, UDI and Basic UDI-DI assignment.
• Plan and support registrations in new markets outside the EU, working with distributors and local regulatory agents.
• Assess regulatory impact of design, supplier and manufacturing changes, and approve change controls with Quality.
• Support CDMO customers with the regulatory part of contract manufacturing agreements and technical files.
• Run regulatory due diligence on acquisition targets and lead integration of acquired product portfolios.
• Build and coach the regulatory team as the business grows.

Conhecimentos

EU MDR

Notified bodies

Docs writing

Risk management

ISO 13485

PRRC eligible

Regulatory strategy

English fluency

Formação académica

Life sciences degree

PRRC eligible

Descrição da oferta de emprego

Panda International seeks a senior Regulatory Affairs leader to own EU MDR strategy for Class III devices, including dermal fillers, and to serve as the main liaison with the notified body. You will lead technical documentation, post-market activities, and registrations for new markets as the business grows.

The role requires hands-on authorship and a track record with MDR conformance, risk management, and clinical evaluation.