Summary
Ability and knowledge to conduct the work listed in at least one of the 5 major job Duties and Responsibilities(excluding General Duties), so that they contribute to company compliance with relevant laws and regulations.
Essential Responsibilities
Regulatory (Supporting Responsibility)
• Actively engage in pre-/post-market regulatory activities, which include but are not limited to the following:
• Review and approval of product labeling.
• Review of FDA submissions.
• Assist/work with consultants as needed.
• Support R&D with 510(k) submissions.
• Create Regulatory Master Plans for product launches.
• Lead the development of new product labeling and oversee the labeling program to coordinate the review, approval, and tracking of all product labeling.
• Act as the subject matter expert on UDI.GUDID regulations.
• Manage FDA facility registrations and device listings.
• Manage FDA import inspections, provide FDA data and information to US Customs, and work with both the FDA and US Customs to resolve shipments placed on hold.
• Write Health Risk Assessments for Nonconforming products, customer complaints and MDRs.
• Review ECRs.
• Support Sales and Marketing to resolve any FDA compliance questions or concerns from customers.
Science (Supporting Responsibility)
• Support Medical Lab Scientists of the Smart Assist project.
• Support clinical studies as needed. Including but not limited to hands-on assistance in the clinical studies.
• Train and support the Clinical Application Specialists and Field Service Engineers in their activities.
• Perform other pre-/post-market activities as assigned.
Quality Assurance/Quality Management System (Primary Responsibility)
• Manage the supplier databases for our major retail-chain partner.
• Manage the Validation Program, Change Control Review, and approve Supplier Change Requests.
• Coordinate the review, approval, and tracking of all Engineering Changes from our suppliers.
• Review and approve ECRs.
• Manage various Quality System databases.
• Oversee software validations.
• Fulfill the role of internal auditor. Also, manage the Internal Audit Program.
• Prepare supplier audits and scorecards. Also, manage the Supplier Approval Program.
• Conduct External Audits.
• Assemble the monthly AOD presentation materials and present the training data.
• Perform Quality Acceptance Inspections on products that are to be delivered to a 3rd-party logistics company and then perform the shipment permission inspection on products that are to be shipped from the 3rd-party logistics company.
• Act as the Quality Plan Manager for Product Launches if required.
• Ensure compliance with FDA QMSR, ISO 13485, and OSHA.
• Fulfill the role of OSHA Safety Coordinator for our Miami Facility and any new facilities that may be added in the future.
• Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required.
• Chair the monthly AOD (Analysis of Data) meeting if required.
• Prepare and present CAPA data at the monthly meeting if required.
Complaint Handling (Supporting Responsibility)
• Oversees Post Market Surveillance - Customer Complaints.
• Create the Monthly Risk Review Report.
• Manage Product Recalls and other field actions.
• Manage our Lab Division’s Complaint Program and coordinate External Complaint with AFC (factory headquarters in Japan).
• Chair the Lab Division’s monthly Complaint Meeting.
• Present the Lab Division’s Complaints in the monthly AOD meeting.
• Review Technical Bulletins.
• Manage the Healthcare Division’s Complaint Program.
• Chair the Healthcare Division’s monthly Complaint Meeting.
• Present the Healthcare Division’s Complaints in the monthly AOD meeting.
• Submit MDRs to the FDA.
• Create the Monthly Vendor Reporting.
• Review the Daily Call Data of our major retail-chain partner.
General Duties
• Act as the Facilities and Equipment Manager of our Miami location.
• Pick up and process company mail.
• Coordinate activities for the Miami Facility and Office.
This job description is not intended to be all-inclusive and the employee will also perform other reasonably related business duties as assigned by management.
Qualifications
Knowledge and Skills
• Bachelor’s Degree in chemistry, biology, engineering or other technical field required.
• Two or more years of experience working in a regulated diagnostic industry required.
• Senior roles will require seven or more years of experience working in a regulated diagnostic industry required.
• Experience working with Class I and Class II medical devices, preferably laboratory, and Point of Care IVD instruments and reagents that are subject to US regulatory submission.
• Knowledge and working experience on FDA, GMP/QSR, ISO, CFR and/or other regulatory issues related to medical devices.
• Senior roles will require the ability to manage both undergoing ISO 13485 audits and conducting supplier audits in compliance with ISO 13485 standards.
• Knowledge on US regulatory submissions. Ability to build direct relationships and deal with the FDA in relation to the submission process is preferred.
• Clinical study management experience is preferred.
• Experience in quality systems and quality assurance activities.
• Proficiency in Microsoft Office programs (including, but not limited to Word, Adobe, Excel, PowerPoint)
• Ability to travel.
Physical Requirements
Heavy keyboarding / PC use
ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities. ARKRAY offers a generous benefit package that includes Medical, Dental, Vision, 401K w/company match, FSA and HSA options.