Compliance Analyst ensuring regulatory compliance through data analysis and monitoring for Prex, a leading LATAM financial platform.
About the role
- Associate Regulatory Affairs Specialist supporting regulatory affairs field actions and compliance within EU for Medtronic. Collaborate with sales teams and regulatory bodies ensuring legislation adherence.
Responsibilities
- Focus on supporting regulatory affairs field actions
- Address inquiries from Competent Authority, customers, tenders, marketing, and sales teams
- Provide guidance and advice to the sales team to ensure compliance with EU and local legislation
- Preparation, execution, and follow-up of FSCA's (Field Safety Corrective Actions)
- Close collaboration with sales managers and sales representatives
- Reconciliation activities in collaboration with the FSCA Support Team
- Follow-up on inquiries related to Field Action or Vigilance activities
- Support on Post-Market Surveillance by advising sales team members
- Monitoring the shared mailbox to provide support for tender requests and customer inquiries
- Sourcing, verifying, and providing regulatory documents
Requirements
- 3-5 years of experience in medical device regulatory, quality, or product-related roles
- Relevant university degree in Regulatory Affairs, Pharmacy, Engineering, or another scientific discipline
- Proficient in Microsoft Office (with advanced Excel skills)
- Autonomous, proactive, detail-oriented, and committed to continuous learning
- Strong administrative and organizational abilities
- Clear and effective communication in English, with additional proficiency in French, Dutch, and/or German
Benefits
- Competitive Salary
- Flexible Benefits Package
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
- Short-term incentive called the Medtronic Incentive Plan (MIP)
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