Associate Regulatory Affairs Specialist

MiniMed

Maastricht

2 days ago

Maastricht

2 days ago

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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.

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Hybrid

Full-time

Entry Level

Regulatory Affairs

Quality Assurance

Salary

Not specified

Work Location

Maastricht, Limburg, Netherlands, NL

Work Model

Hybrid: minimum two days per week in one of our offices in Paris, Maastricht, Heerlen, or Eindhoven

Experience Required

5 years

Employment Type

Full-time

Experience Level

Associate

Core Qualifications

Technical (Must-have)

Regulatory AffairsQuality AssuranceEU regulationsField Safety Corrective ActionsPost-Market SurveillanceCompetent Authority submissionsMicrosoft OfficeAdvanced ExcelOrganizational software

Soft Skills

CommunicationIntegrityContinuous LearningInterpersonal EffectivenessTime ManagementAutonomyPro-activityAttention to DetailOrganizational skills

Tools (Must-have)

Microsoft OfficeExcel

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

Core Qualifications

Technical (Must-have)

Regulatory AffairsQuality AssuranceEU regulationsField Safety Corrective ActionsPost-Market SurveillanceCompetent Authority submissionsMicrosoft OfficeAdvanced ExcelOrganizational software

Soft Skills

CommunicationIntegrityContinuous LearningInterpersonal EffectivenessTime ManagementAutonomyPro-activityAttention to DetailOrganizational skills

Tools (Must-have)

Microsoft OfficeExcel

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.