Maastricht
2 weeks ago
Associate Regulatory Affairs Specialist
MiniMed
Maastricht
2 weeks ago
Associate Regulatory Affairs Specialist
MiniMed is seeking an Associate Regulatory Affairs Specialist to support regulatory and quality activities across Benelux and France. The role involves field actions, post-market surveillance, and collaboration with internal and external stakeholders in a hybrid work environment.
HybridFull-timeEntry LevelCompetent Authority SubmissionsField Safety Corrective Actions
Associate Regulatory Affairs Specialist
MiniMed is seeking an Associate Regulatory Affairs Specialist to support regulatory and quality activities across Benelux and France. The role involves field actions, post-market surveillance, and collaboration with internal and external stakeholders in a hybrid work environment.
HybridFull-timeEntry LevelCompetent Authority Submissions
Salary
Not specified
Core Qualifications
Technical (Must-have)
Competent Authority submissionsField Safety Corrective ActionsEU regulationsRegulatory AffairsPost-Market SurveillanceAdvanced ExcelOrganizational softwareQuality AssuranceMicrosoft OfficeExcel
Soft Skills
CommunicationIntegrityContinuous LearningInterpersonal EffectivenessTime ManagementAutonomyPro-activityAttention to DetailOrganizational skills
Key Responsibilities
- Preparation, execution and follow-up of FSCA's (Field Safety Corrective Actions) according to enterprise plan.
- Follow-up on inquiries from Competent Authority regarding Field Action or Vigilance activities.
- Support on Post-Market Surveillance and advise sales team on product complaint handling.
- Monitor shared mailbox and support tender, customer, and internal stakeholder requests.
- Source, verify, and provide regulatory documents to customers and stakeholders.
- Connect requests to appropriate teams ensuring complete follow-up.
- Collaborate with peers in EMEA to share experience and knowledge.
- Participate in Quality and Regulatory improvement initiatives.
Regulatory AffairsQuality SpecialistMedical DevicesHybridBeneluxFranceFSCAPost-Market Surveillance