BD (Becton, Dickinson and Company) Regulatory Affairs Compliance Manager in Salt Lake City, Utah
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.
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.
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.
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.
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.
This position is in an office and requires the incumbent to perform general office functions.
The ideal candidate must be able to work in a team oriented, fast paced environment. Bard Access Systems is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
Industry Standard/Category: Medical Device/ Regulatory Affairs
Career Level: experienced
Division Name: Salt Lake City, UT/ Vascular Access Devices - MDS
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 605 North 5600 West
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.