BD (Becton, Dickinson and Company) Sr. Regulatory Affairs Specialist in Salt Lake City, Utah
Job Description SummaryBD 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 C.R. Bard domestic and international regulatory affairs (RA) procedures.
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.
• Serves as RA representative and provides regulatory guidance on product teams as assigned and signs test protocols and reports as required
• Develops and administers new product field trials as required
• Coordinates the collection of data and information for regulatory submissions and writes the required regulatory submissions for new BAS products
• Reviews and approves documentation Change Requests and labeling artwork changes per BAS and corporate SOPs
• Performs GMP/ISO 13485 audits as requested by Department Head
• Performs special projects, such as administering recalls, as required by Department Head
• Supports and/or maintains FDA medical device listing/registration information as requested for BAS and other Bard designated manufacturing facilities
• As requested, serves as alternate BAS facility FDA inspection coordinator
• Prepares and submits PMA annual report and approves PMA related Change Requests
• Depending on the product team assigned, serves as the BAS international information contact person, coordinates the preparation of BAS international dossiers with the assigned product teams and updates them as required
• Travels as required, perhaps on short notice, as assigned
• On assignment, implements or oversees the preparation of Investigational Device Exemption (IDE) protocols between BAS Medical Affairs office, BAS Clinical Affairs, and product teams. May work with contract research organizations to develop and implement clinical trial protocols
• Coordinates and manages updates to Technical Files and Design Dossiers, including the Essential Requirements documentation and Clinical Evaluation Reports, to comply with EU regulations
• Develops quality reports, protocols and submissions; ensures the accuracy and timeliness of data collected; and gains acceptance of regulatory authorities for information submitted
• Plays a key role in the clinical evaluation process and regulatory activities
• Responsible for evaluating and ensuring activities are in compliance with applicable FDA regulations and C.R. Bard policies
• Excellent understanding of US, CE and international regulatory requirements
• Solid scientific analytical evaluation skills
• Ability to work independently with little supervision
• Ability to multi-task and manage several projects at a time
• Ability to handle stressful situations (e.g., FDA or Notified Body audits) in a professional manner
• Excellent writing ability is a must
• Ability to work in a stressful, fast-paced environment
• Ability to manage and handle responsibility for compliance activities, which have the potential for serious impact on the Company’s business, image and reputation
• Strong ability to influence team projects to improve regulatory success via strong regulatory knowledge and skills, and team collaboration
Education and/or Experience:
This position requires:
Bachelor's Degree in a Life or an Engineering Science,
Plus five (5) or more years US, CE and international regulatory affairs experience
Exposure to GMP/ISO 13485 training
Demonstrated excellent writing skills
Experience with MDR and vigilance reporting determination, or equivalent
Experience representing Regulatory Affairs on a cross functional team
Understanding and knowledge of Quality Systems regulations and 21 CFR 820
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
This position is in an office environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching are also frequently required.
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.
Primary Work LocationUSA UT - Salt Lake City BAS
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status