Post Market Surveillance Senior Specialist
Post Market Surveillance Senior Specialist
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Job Description
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
Required Experience:
Senior IC
Employment Type
Full-Time
