Job SummaryWe are seeking an experienced
Distribution Compliance Specialist to oversee and ensure global regulatory compliance for the distribution of our Class I and Class II medical devices.
This role is responsible for distribution licensing, labeling compliance, import and export product regulatory requirements, and customs documentation for product clearance. The position works cross-functionally with Regulatory Affairs, Logistics (international shipping), and International Sales to ensure compliant and efficient global distribution.
This role focuses strictly on medical device regulatory and compliance oversight and does not include responsibility for commercial or business negotiations with distributors, nor does it include Logistics customs clearance. This role does not manage pricing, sales targets, or business negotiations.
The position utilizes technical expertise on the 21 CFR 820, ISO 13485, ISO 14971, EU MDR for Class I and Class II medical devices, including capital equipment and accessories. This position supports Mizuho OSI in achieving established goals and objectives and follows the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI.
Responsibilities:- Ensure that Mizuho OSI approved distributors adhere to all country specific quality and regulatory requirements of Class I and Class II as well as the requirements of International Distributor Agreement (IDA).
- In partnership with Global Supply Chain and International Sales, implement Distributor Compliance Program including processes for evaluating and qualifying new distributors, audits and periodic assessments against the IDA, establishing compliance performance metrics (KPI) and remediation plans for identified non-conformities.
- Monitoring Distributor performance against defined quality metrics and objectives. Maintain and improve KPIs and data management tools to monitor quality metrics and data related to external distributors.
- Participate in the development and implementation of quality procedures, and processes aligning with GMPs and applicable regulations. Design and maintain Distributor Regulatory Requirements documentation by country. Ensure distributors are registered with local competent authorities where required (e.g., MDEL in Canada, SFDA MDNR in Saudi Arabia).
- Maintain a centralized repository of Distributor documentation: agreements, periodic evaluations, complaints, and incident reports. Ensure Distributor has proper traceability of distributed devices per regulatory record retention requirements.
- Develop and deliver training to distributors on post-market obligations: complaint handling, adverse event reporting, recalls, etc.
- In collaboration with RA team, support non-conformities, including serious incidents and field safety corrective actions.
- Partner with International Sales Regional manager for customer complaint handling related to device safety or performance incidents reported in territories managed by distributors. Provide regulatory support to facilitate compliant international shipments and resolve customs-related holds or inquiries.
- Review and approve changes to distributor processes that may impact device quality or compliance. Depending on the scope of activities (e.g., repackaging, relabeling), a distributor may need assistance in implementation of additional quality management system elements (e.g. traceability, ensuring proper storage and transport conditions, etc.); consult and provide guidance to distributor for compliance to standards like ISO 13485, EU MDR or other applicable regulations.
- Work closely with multi-functional teams and system owners to lead and support continuous improvement initiatives related to distributor quality and compliance.
- Responsible for a professional work area to include cleanliness, organization, and overall department appearance.
- Further improve or develop skills to interpret complex regulations, identify compliance gaps, and address regulatory ambiguities. Be willing to share knowledge and instruct other members of the department and the company, by passing along skills and information to assist them in their development.
- To help create an ongoing effort through personal action and by contributing ideas to support both the department and Company's ongoing improvement efforts.
- Understand Mizuho OSI's business objectives and the relationship between the Department and those objectives; to support and follow the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI, and to continually enable Mizuho OSI to be a great place to work.
- Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
Qualifications & Requirements:- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field with 10-12 years of regulatory experience particularly in the international market. RAC certification is a plus. 8 to 10 years of medical device industry experience.
- Experience with and ability to interpret applicable standards/directives: ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and international regulatory requirements of country specific.
- Ability to work independently and collaboratively with small and cross functional teams.
- Ability to efficiently and effectively use Microsoft Office 365, particularly Outlook, Word, Excel, Teams, Project, Visio and PowerPoint to analyze data, produce trend charts and presentation.
- Ability to clearly express oneself verbally in the English language (additional languages also preferred) using good grammar, vocabulary, eye contact, and friendly voice inflection with all employees. Ability to communicate effectively with employees and other business contacts in a courteous and professional manner.
- Excellent customer focus with a high sense of urgency to create positive experiences, and if applicable, resolutions. Ability to provide excellent interpersonal and communication skills.
- Ability to function calmly in a fast-paced environment managing multiple priorities simultaneously.
- Ability to clearly and effectively express oneself through written means, to properly use such technical factors as grammar, punctuation, vocabulary, and correct spelling. To be able to prepare business letters, memorandums, and reports. Excellent verbal and written communication skills, strong presentation, project and organizational skills.
- Ability to perform basic statistical analysis, calculating C&R, create and reconcile reports, demonstrate strong analytical skills, and attention to detail.
- To respond sensitively to the needs and feelings of others regardless of position; to accept interpersonal differences, to maintain rapport, and to interact effectively with all levels of employees within the organization.
- Ability to demonstrate an understanding, and the regular use of a time management process, which systematically structures one's own work to provide for effective task performance and to plan and prioritize items to meet future demands.
- Ability to establish and accomplish goals independently and to function as a positive and productive team member.
- Neat and professional appearance and outgoing people-oriented personality which conveys pride in working for Mizuho OSI and which is demonstrated with a ready smile and a willingness to assist others.
Salary range $136,000- $162,000 DOE + potential annual bonus + comprehensive benefits package
