Quality Assurance & Regulatory Affairs Assistant Manager

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Job description

Hurricane Medical is a manufacturer and worldwide distributor of class 1 and class 2 single use ophthalmic microsurgical instruments, located in Bradenton, FL. Reporting directly to the RQ/QA Head, the QA/RA Assistant Manager is a "Hands On" entry level position working with and learning from the RQ/QA Head to maintain and ensure that the Company's Quality Management System complies with FDA, MDSAP, MDD/MDR, ISO 13485 and other international medical device regulatory standards.

Range of Duties and Responsibilities

Ÿ The QA/RA Assistant Manager will act as the management representative for Hurricane Medical. The duty of this task is act as the point of contact for all regulatory communication in the company, including incident reports, audits, registrations, etc.

Ÿ Administrates compliance with FDA and Foreign establishment registrations, product registration databases including GUDID and EUDAMED, UDI, product complaints, CAPA, management review, etc.

Ÿ Establish, manage and maintain compliance with MDD 93/42/EEC and or MDR for class 1 and class IIa devices, including CE marks, clinical evaluations, risk management activities, and technical files.

Ÿ Administers the quality and regulatory control for products in which Hurricane Medical is the legal Manufacturer.

Ÿ Manage and maintain compliance to ISO13485 and ISO 13485 MDSAP requirements.

Ÿ Responsible for responding and reporting incidents to all approved markets.

Ÿ Manages the Customer Complaint System.

Ÿ Coordinates the management of product failures, investigations, and appropriate corrective actions.

Ÿ Responsible for quality document review, new document implementation, and document control.

Ÿ Works with management to define, track, and report the Company's quality objectives on a quarterly basis.

Ÿ Ensures the maintenance and reviews all process and sterilization validation activities.

Ÿ Responsible for microbiological monitoring activities.

Managerial Responsibilities

Ÿ Works with the RA/QA Head to manage the Quality Assurance and Regulatory department.

Ÿ Manage and direct two quality assurance technicians.

Ÿ Work closely with the manufacturing, engineering, and Marketing/Sales departments as needed.

Education and Experience

Ÿ AS, BS degree within a science discipline, or 2+ years' experience in Quality Assurance and or Regulatory affairs.

Ÿ An ambitious person who is willing to continue their education concerning all aspects of the medical device RA/QA profession.

Ÿ A goal-oriented person driven by purpose who can focus on the tasks at hand and get them done efficiently and in a timely manner.

Compensation

Beginning wage dependent upon level of experience.

We offer health insurance, a 401(k) plan after one year employment, accrued two week vacation and one week sick time.