- 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:
- ABachelors degreeinBiomedical Scienceor a related field (preferred).
- 2-3 years of experiencein a regulated medical device or clinical environment.
- Proficiency in English(both written and spoken).
- Strongcomputer skillsfor data evaluation, regulatory reporting, and correspondence.
- Experience in pharmacovigilance, medical device vigilance, ornursing(preferred).
What s in it for YOU
- Competitive salary and benefitspackage, including a lunch card, wellness allowance, and employee discounts.
- Flexible work optionsand work-from-home opportunities.
- Professional developmentwith training allowances and career growth opportunities.
- Generous holiday daysand share incentives
