Sr. Regulatory Compliance Specialist
Verathon
Amsterdam, Netherlands
4 dagen geleden

Principal Responsibilities :

  • Serve as Deputy Management Representative for Verathon Medical EMEA’s ISO 13485 certified quality management system : Ensure that processes needed for the quality management system are established, implemented, and maintained, such as quality policy, quality objectives, documentation and records, internal and external audits and management reviews.
  • Report to top management on the performance of the quality management system and any need for improvementEnsure the promotion of awareness of regulatory and customer requirements throughout the organization.

    Liaison with external parties (National Competent Authorities and Notified Bodies) on matters relating to the quality management system.

  • Serve as EU Authorized Representative for regulatory compliance for Verathon Medical EMEA’s CE-marked medical device products : Serve as designee for Verathon corporate Regulatory Affairs person to register Verathon devices with the National Competent Authorities (NCA) before they are marketed, where applicableAct as Verathon’s primary contact point for all NCA, with full contact availabilityMaintains access to Technical Files including MDD Essential Requirements Checklists (ERC), General Safety & Performance Requirements (GSPR), Declarations of conformity (DoCs) and other regulatory documents, for inspection by the European Competent authorities for the purpose of market surveillanceMaintain oversight of the supply chain economic operators for CE-marked productsAssist with incident and Field Safety Corrective Action (FSCA) reporting to the NCA and Notified Bodies in conjunction with the Legal Manufacturer and EMEA DistributorsRepresent Verathon for consultation with the European Commission in case of withdrawal of a medical device by a Member StateReviews vigilance events and trends in line with expectations for post-market surveillance
  • Maintain regulatory intelligence to inform and influence Verathon decision-makers in the evolving demands and expectations of European quality systems, quality auditing, and regulatory requirements : such as Medical Device Directive (MDD), Medical Device Regulation (MDR), Restriction of Hazardous Substances (RoHS) Directive, etc.
  • Support timely and effective new product launches to the EMEA markets in collaboration with cross-functional team members
  • Support review and approval of substantial changes, labeling (IFU) changes, translations, technical documentation to assure continuing compliance to CE-marking requirements
  • Other duties as assigned
  • Knowledge, Skills, and Abilities :

  • Bachelor’s Degree in a Scientific or Engineering field required.
  • A minimum of 3 years’ experience in compliance and / or quality system activities in a QSR / ISO 13485 Quality Management System and MDSAP audits
  • Knowledge of the following regulatory requirements is required : GMPs, MDD / MDR
  • Knowledge of RoHS Directive, GDPR, and REACh regulation preferred
  • Demonstrated knowledge, understanding or application of audit principles, concepts, and practices related to a regulated quality system
  • The ability to complete regulatory reports and provide timely, written correspondence to internal and external customers including regulatory bodies
  • Must have excellent oral and written communication skills with ability to maintain composure under pressure
  • Must possess strong organizational skills with the able to manage time for completion of tasks across independent projects or program deliverables, while effectively balancing priorities
  • Must have the ability to handle confidential data
  • Must be a critical thinker and detail-oriented with strong problem-solving skills
  • Strong desire to work within a collaborative, productive, and empowered cross-functional team
  • Lead Auditor or ASQ Certification is preferred
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