Senior Regulatory Affairs Specialist

4 semanas atrás


Lisboa, Portugal Bausch + Lomb Tempo inteiro

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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