We at Medzon Health are here for you, the people. We are an American based company that took a different approach in the COVID-19 pandemic. We provide PPE not only to major healthcare systems but also to clinics, factories, retailers, and last but not least the public consumer. Our partnerships with local as well as international factories give us an edge in delivery optimization with the ultimate goal of transitioning the majority of the production to the US. Our commitment to providing safety to use supplies is achieved through FDA, NIOSH & CE approvals, and certifications.
Medzon is looking for a candidate with experience in medical supplies which will be surgical tie mask, surgical gowns, medical gloves, and with experience in FDA(510K) and NIOSH.
The post holder will assist in the monitoring of multiple global suppliers to ensure regulatory compliance, generate metrics and prepare reports for the regulatory department.
- Perform Regulatory Affairs activities ensuring compliance with applicable regulations and requirements (FDA, HC, MHRA, HPRA), including but not limited to
- Oversee and contribute to the preparation of regulatory submissions and registrations
- Manage submission timelines, monitor approval status and communicate change status to concerned parties in a timely manner
- Prepare, review and/or approval of regulatory change controls, risk assessments
- Respond to Competent Authorities’ queries and deficiencies in a timely manner
- Monitor and interpret new and existing regulations
- Liaise effectively with internal departments and external suppliers to support the timely introduction of new products to market
- Operate medical communications line in accordance with supplier SDEA
- Ensure the effective implementation of a quality management system in the Regulatory function
- Work as a team member in developing the regulatory oversight of suppliers
- Preparation of monthly metrics and reports to monitor and cross-compare the quality systems
- Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business
- Be flexible within the Regulatory function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience
- Support cross-training opportunities and skills
- Provide day-to-day department support activities as necessary to aide completion of project deliverables
- Perform general duties as required by the Regulatory Manager
$66,000.00 – $85,983.00 per year
Monday to Friday