Quality & Regulatory Affairs Director

FloodGate Medical•Tampa, FL

19h•$150,000 - $175,000

About The Position

The Quality & Regulatory Affairs Director will lead quality and regulatory operations at BIOREP Technologies , a boutique medical device design and manufacturing partner supporting cardiovascular and electromechanical device programs. This role is responsible for maintaining and strengthening the company’s ISO 13485 Quality Management System, ensuring audit readiness, and supporting regulatory compliance across both internal products and customer manufacturing programs. The Director will oversee a small quality team while remaining hands-on with CAPA management, investigations, and continuous quality improvement initiatives.

Requirements

Bachelor’s degree in biomedical/life science or related industry
+10 years previous experience in FDA/ISO 13485 regulated environment

Nice To Haves

ASQ Certification in Manager of Quality/Organizational Excellence or equivalent preferred
ASQ Certification in Quality Auditor or equivalent preferred
Previous audit experience preferred
Previous experience in application of risk management to the requirements of ISO

Responsibilities

Identifying and maintaining QMS records and the Record Retention Matrix
Creating and storing quality records based on job assignments
Establishing QMS procedures including preservation of product and calibration of equipment
Approving documents and the document control procedure; applying the document control requirements
Verifying acceptance of in-coming purchased materials / product
Establishing of product identification codes and descriptions
Establishing the method(s) and records for product traceability
Securing suspect and non-conforming materials/product
Conducting review/evaluation of material issues and returned/recalled product
Initiate NCMs, Corrective Actions, Preventative Actions in quality software
Authorizing product release and disposition of materials
Leading supplier qualifications, supplier evaluations and re-qualifications
Establishing, implementing, and maintaining the QMS Audit Program including performing audits
Intake and evaluation of customer inquiries to identify complaints, request product returns, issue recall notices, reports to regulatory authorities, and records of a customer complaint procedure
Collecting and analyzing of quality performance data
Segregating and controlling past-due shelf life, contaminated or potentially contaminated product
Participating in QMS audits and timely response to assignments from the audit
Investigating and implementing Corrective Actions
Completing an assigned Preventative Action
Establish quality policy
Establishing and monitoring quality objectives
Planning and initiating changes to the Quality Management System
Defining responsibilities and authorities
Management Review
Verifying the implementation and effectiveness of corrective and preventative actions
Analyzing and evaluating results of internal, third party and customer audits
Initiate Health Hazard Evaluations and all consequent actions
Direct, manage and organize regulatory affairs activities for current and future medical device products (FDA Class I and II)
Create, update, and maintain internal SOP’s to comply with ISO 13485 and FDA regulatory requirements
Review product labeling and promotional materials to ensure compliance with regulatory requirements
Define the regulatory strategy for preparing US and OUS device submissions (510k application)
Ensure up to date compliance with changing FDA and ISO regulations
Provide top management with appropriate metrics and information to present during management review meetings
Take the leadership role for internal/external audits
Promote compliance within the organization
Being or Assigning the FDA Management Representative
Other duties as assigned