Assistant Manager, Sales Support Division, Regulatory Team

ARKRAY USA, Inc.•Doral, FL

30d

About The Position

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.

Requirements

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.

Responsibilities

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.
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.
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.
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.
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.