Complaint Management:
Review and process product complaints, ensuring adherence to both internal procedures and external regulations.
Regulatory Reporting:
Determine regulatory reporting requirements and manage Health Authority Requests in compliance with EU MDR 2017/745 and other relevant global regulations.
Investigation Support:
Facilitate and oversee complaint investigations, working closely with relevant teams and creating follow-up questions to ensure thorough evaluations.
Audit and Compliance:
Support regulatory audits and compliance reviews. Maintain a deep understanding of quality system policies and regulatory guidelines.
Customer Satisfaction:
Enhance customer satisfaction by ensuring quick response times and effective resolution of issues.
Team Development:
Participate in onboarding and training of new team members to foster a knowledgeable and high-performing team.
Continuous Improvement:
Contribute to process improvement initiatives, working toward achieving operational excellence and meeting business goals.

Qualifications:

We would love to hear from you if you have the following qualifications:

A Bachelors degree in Biomedical Science or a related field (preferred).
2-3 years of experience in a regulated medical device or clinical environment.
Proficiency in English (both written and spoken).
Strong computer skills for data evaluation, regulatory reporting, and correspondence.
Experience in pharmacovigilance, medical device vigilance , or nursing (preferred).

What s in it for YOU

Competitive salary and benefits package, including a lunch card, wellness allowance, and employee discounts.
Flexible work options and work-from-home opportunities.
Professional development with training allowances and career growth opportunities.
Generous holiday days and share incentives

Vigilance Specialist