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Senior Regulatory Affairs Specialist
2 semanas atrás
Regulatory Affaris Specialist Medical Devices
**JOB OVERVIEW**:
**Regulatory Affairs**: Manages all regulatory activities in Portugal for the Bausch + Lomb medical devices portfolio. Leads local, regional, and global projects (as applicable) and performs all necessary regulatory activities for Bausch + Lomb medical devices.
**Materiovigilance**: Ensures the company is in a continuous state of Vigilance compliance, in line with company's procedures and policies, including local specific and other applicable standards and regulations.
**KEY ACTIVITIES**:
**Regulatory Affairs - Medical Devices**:
Managing the Portugal medical device database entries
Reviewing and approving advertising and promotional materials
Performing Health Authority notifications
Conducting Change evaluations for impact to the Portuguese market
Supporting tenders
Verifying packaging and labelling artwork meets local requirements
Supporting Field Safety Corrective Actions
Staying current on national and European legislation
Participating in regulatory policy and intelligence activities
Supporting regional/global projects as applicable
Materiovigilance
Managing Materiovigilance activities
Ensure local compliance with applicable Medical Device Vigilance regulations
Act as key contact for Materiovigilance with the local Heath Authority in the territory
Support company Medical Device vigilance activities
Support GDCM and requirements for materiovigilance agreements with local third parties
**QUALIFICATION**:
Degree BS in scientific discipline (e.g. Pharmacy).
5+ years’ experience in regulatory affairs, quality or compliance for medical devices.
Strong knowledge of legislation for MDD (93/42/EEC) and MDR (EU 2017/745)
Strong knowledge of ISO 9001:2015 and ISO 13485:2016 of medical devices
Fluent written and spoken English and Portuguese
Experience working in cross-functional teams
APPLY NOW
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