Post Market Surveillance Senior Specialist

Work Flexibility: Hybrid

We are looking for a Post Market Surveillance Senior Specialist to join our PMS EMEA team in Bucharest.

What you will do:

Execute PMS activities in line with defined procedures and processes.

Implement post market strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities)

Report product safety issues to regulatory authorities as required, to comply with local, regional and global regulations

Assess regulatory intelligence to assist in the development of local, regional regulatory strategies

Collect local, national, international Post Market Surveillance requirements and options for regulatory submission (adverse events) and compliance activities

Identifie the need for new post market procedures, SOPs and participates in development and implementation

Support the development and deployment of new systems and procedures locally

Support continuous improvement activities across PMS processes at the regional level

Support integration of new acquisitions & PMS processes alignment

Liaise with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizations

Provide support to EMEA / Country RAQA teams and included activities sitting under the franchise lead role when requested

Prepare regular reports as requested: weekly / monthly reports, support quality management meetings and audits preparation and readiness

Identify training needs, develop training materials and deliver training at any organizational level

Assist other departments in the development of SOPs to ensure post market compliance

What you need:

BS in Engineering, Science, or related degree; or MS in Regulatory Science

Minimum 2 years’ experience

Experience in a highly regulated industry (Medical or Pharma)

Knowledge of Medical Device Directive (EU/FDA) and Regulations

Fluency in English

High attention to detail and process consciousness

Good communication and analytical skills to engage with regulators and other key stakeholders on routine and complex matters

Travel Percentage: 10%

R540755