About the Role:Reporting to the Manager of Regulatory Affairs and Quality Compliance, the Senior Regulatory Affairs Associate will play a vital role in ensuring global regulatory compliance, supporting EU MDR projects, and handling technical documentation for submissions and audits. This role is ideal for an experienced professional with a strong background in regulatory compliance, quality assurance, and new product registration.
This position is for an open vacancy.
The successful applicant will:- Provide technical support for regulatory submissions and compliance requirements.
- Manage scientific, medical, clinical, and manufacturing documentation for new product registrations.
- Act as a resource on regulatory matters, including government requests and product changes.
- Lead EU MDR projects and ensure alignment with global regulatory standards.
- Develop, update, and maintain internal quality procedures and product documentation.
- Prepare and maintain Technical Files and Design Dossiers for CE Marking.
- Support audits from FDA, Notified Bodies, Competent Authorities, and other regulatory agencies.
- Conduct internal and external audits, monitor compliance trends, and manage risks.
- Assist with post-market compliance, complaint handling, and technical file tracking.
- Represent LUVO as a Regulatory Representative, ensuring industry-leading compliance.
We are seeking a candidate with the following experience and attributes:- Bachelor's degree in science or a related field.
- 3-5 years of experience in a Regulatory Affairs role.
- Strong research, logic, attention to detail, computer expertise, and medical knowledge.
- Familiarity with EU MDR 2017/745, HPB guidelines, and global compliance standards.
- Ability to interpret and apply regulatory requirements to ensure company-wide compliance.
