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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
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
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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