Regulatory Affairs & Quality System Program Manager

Varian Medical Systems, Inc. Atlanta, GA
Job Description

The Regulatory Affairs & Quality System Program Manager will responsible for managing and maintaining quality system components specific to the Velocity group at Varian and interfacing with the broader Varian quality and regulatory group.

Primary responsibilities will be:

* Develops, implements, and maintains quality system and control systems and activities including quality system internal and external audits, quality assurance support of development projects, CAPA, complaint handling, and the QMS documentation.

* Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products

* Participates in the reviewing of engineering designs to contribute quality requirements and considerations

* Assists product support areas in gathering and analyzing data

* Selects, develops, and evaluates personnel to ensure the efficient operation of the function

* Performs all required management responsibilities including but not limited to: implementing the company's policies, programs, and guidelines; ensuring employee productivity and growth; knowing Varian's business; and maintaining functional, technical, and external market awareness necessary for managing immediate organization

* Oversees local regulatory activities. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies and hosts audits.

* Supports timely preparation of organized and scientifically valid applications for country registrations.

Job Requirements

Bachelors degree (or equivalent experience) and 5 years of related experience or Masters Degree with 3 years of related experience

In depth knowledge of quality systems for medical device software, ISO 13485 class quality systems

Quality system auditor

Experience with software design and development processes

Regulatory affairs experience including hosting audits and market clearances

Ability to write and support quality system documentation

Must be self-motivated, goal-driven and detail-oriented individual

Must be capable of working effectively in a team environment and have excellent communication and presentation skills

Must be living in or willing to relocate in the Atlanta, GA area

Additional desired skills:

Experience with project management including project planning and tracking.

Experience developing clinical medical device software applications.

Experience with risk management and ISO 14971

MBA preferred

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