Global Regulatory Affairs Specialist, Medical Devices

Envista Holdings Corporation; Brea (CA); Vor Ort; USD 86.000 - 105.000; Vollzeit

Zusammenfassung

Envista Holdings Corporation is seeking a Regulatory Affairs Specialist to create, evaluate and manage regulatory tasks for worldwide product registrations, CE files, CERs, SSCPs, PSURs, and PMS reports. This role requires on-site presence at least four days a week in the California facility.

You will collaborate with cross-functional teams to ensure country-specific requirements are met and integrated throughout design control and post‑market activities, driving market growth and compliance.

Qualifikationen

• Bachelor's Degree with 2+ years regulatory affairs in medical devices or regulated industry.
• Master’s degree and 1+ year regulatory affairs experience considered.
• Strong knowledge of EU MDR including CER/SSCP/PSUR and PMS.

Aufgaben

• Assemble and maintain CE technical files per regulatory requirements.
• Prepare and review CER, SSCP, PSUR, and PMS reports.
• Monitor regulatory changes and assess impact on operations.
• Develop SOPs and documentation to support compliance.
• Collaborate with global registration teams on product registrations.
• Coordinate regulatory strategies and timely submissions.
• Submit and maintain regulatory registrations for global markets.
• Advise on regulatory requirements across countries.

Kenntnisse

Regulatory affairs

Cross-functional collaboration

Attention to detail

Project management

Communication skills

Ausbildung

Bachelor's Degree in regulatory affairs/related field

Master’s Degree (preferred)

Tools

MS Office

Jobbeschreibung

Envista Holdings Corporation is seeking a Regulatory Affairs Specialist to create, evaluate and manage regulatory tasks for worldwide product registrations, CE files, CERs, SSCPs, PSURs, and PMS reports. This role requires on-site presence at least four days a week in the California facility.

You will collaborate with cross-functional teams to ensure country-specific requirements are met and integrated throughout design control and post‑market activities, driving market growth and compliance.