Regulatory Affairs Compliance Manager

BD (Becton, Dickinson and Company) Salt Lake City, UT
Category: Medical Device/ Regulatory Affairs

Job ID: 2018-11681

Career Level: experienced

Division: Salt Lake City, UT/ Vascular Access Devices - MDS

Relocation: No

Location: Salt Lake City,Utah,United States

Overview:

BARD has now joined BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

Vascular Access Devices, a sub-business unit of Medication Delivery Solutions, focuses on developing, manufacturing, and distributing high-quality medical devices used by clinicians throughout the worldwide healthcare industry to access a patient's vasculature. Our devices assist in the delivery of chemotherapy, blood products, antibiotics, and nutrition.

Summary of Position with General Responsibilities:

This position implements FDA compliance, MDD compliance, and C.R. Bard regulatory policy and process compliance. This position may also act as a liaison to Corporate Law Department, providing requested information.

Essential job Functions:

The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

* Responsible for implementing and maintenance of C.R. Bard and Bard Access Systems regulatory policy and procedure in compliance with relevant laws and regulations.

* Responsible for FDA Device Listings, Establishment Registrations, Annual Reports, and compliance to and maintenance of state licensing.

* Responsible for regulatory management of new FDA requirements (e.g., UDI) as they become known.

* Responsible for supporting FDA audits of the BAS facility.

* Responsible for MDD compliance, preparation and maintenance of EU Design Dossiers and Technical Files.

* Responsible for Notified Body Technical File Audits, and supporting other Notified Body Audits.

* Domestic and International travel as required.

Basic Qualifications:

* Bachelor's Degree in Life or Engineering Science.

* Eight (8) years regulatory affairs experience or equivalency, or six (6) years with post-graduate degree.

* Extensive knowledge of U.S. FDA regulations, policy and procedure.

* Extensive knowledge and experience with the MDD and CE marking, including surveillance and technical file audits.

* Knowledge of product registration requirements in Australia and Canada.

* Demonstrated communication and human relation skills.

The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

Additional Desirable Qualifications Skills and Knowledge:

* Understanding of US, CE and international medical device regulations.

* High scientific, analytical evaluation skills.

* Good written and oral communication skills.

* Ability to manage direct reports and diverse projects.

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