Post Market Surveillance Senior Specialist

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

• C ollect 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