Lead, direct and be responsible for overseeing and ensuring compliance to Regulatory Affairs, Quality System Regulations, Quality Management Systems and Quality Assurance/Control requirements in both domestic and global markets for all activities at Zilia. Develop the Regulatory strategy to support Zilia’s strategic plans. Acts as Management Representative in reporting to management on performance measures for quality improvements and compliance.
Duties and responsibilities
- Develop regulatory strategies for U.S. EU, Canadian and other markets.
- Serve as Official regulatory agencies correspondent.
- Host regulatory agencies audits.
- Complete annual registrations.
- Review and interpret regulatory rules as they relate to Zilia products and processes. Set up Quality System policies and procedures to ensure their compliance with FDA 21 CFR, Part 820, Medical Device Regulation 2017/745 and ISO 13485 requirements.
- Conduct ongoing company-wide trainings on regulatory agencies and ISO requirements.
- Assess need for regulatory registrations and act accordingly.
- To be responsible for the Document Control process and the efficient control of all documentation required by regulatory agencies.
- Oversee inspection and Device History Records activities.
- Perform Management Reviews and advise management of any product or process related issues and make recommendations for improvements.
- Manage internal audit activities and corrective actions.
- Manage the CAPA process.
- Manage the Complaint Handling process and Medical Device Reporting activities.
- Manage the Nonconforming Material process. Overlook the administration and disposition of nonconforming materials.
- Manage supplier qualification activities and monitor suppliers’ performance.
- Promote a positive working environment conducive to a team atmosphere.
- Responsible for regulatory compliance and ensure that:
- the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released;
- the technical documentation and the applicable declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance obligations are complied with in accordance with applicable regulations;
- the reporting obligations are fulfilled;
- in the case of investigational devices, the appropriate statement is issued.
For this position it is necessary to have an advanced understanding of medical devices and their use, as well as understanding of the regulatory and quality assurance processes.
- Bachelor’s degree in life sciences, technical/engineering, or a related field.
- 8+ years of experience in Regulatory Affairs and/or Quality.
- Leadership experience in the medical device industry, with responsibilities for managing others.
- Demonstrated proficiency in Regulatory Affairs.
- Ability to read, understand and interpret, FDA, EU and Health Canada medical device regulations and requirements.
- Knowledge of ISO 13485 and MDSAP.
- Excellent communication skills required, written and verbal, French and English.
- Updates management on new regulatory issues.
- Ability to read, understand and interpret contractual agreements, legal documents, and advanced technical articles.