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ARKRAY USA · 1 month ago

Assistant Manager, Sales Support Division, Regulatory Team

Doral, FL, USA

Full-time

Onsite

Mid, Senior Level

2+ years exp

ARKRAY USA is a company focused on compliance in the medical device industry, and they are seeking an Assistant Manager for their Sales Support Division, specifically within the Regulatory Team. The role involves engaging in regulatory activities, managing quality assurance processes, and overseeing compliance with FDA regulations.

Health CareMedicalMedical Device

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

Qualification

FDA submissionsISO 13485Quality AssuranceRegulatory complianceClinical study managementMicrosoft OfficeCommunication skillsTeam collaboration

Required

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

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

Preferred

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