Vigilance Specialist

• 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