Job Description: Summary
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
This position will be working in BD-Medication Management Solutions on Regulatory Affairs projects that may span the Infusion, Dispensing and Technology Solutions portfolios. This role will carry out related regulatory affairs activities, such as development, execution and management of submissions, development and review of procedures and systems designed to support the regulatory processes, and address global regulatory requirements as well as the objectives of the business.
This position is responsible for support of a variety of regulatory activities and projects, and/or personnel. This position will provide guidance to project teams as well as other RA teams, develop and implement processes and systems, and stay abreast of global regulations to help MMS achieve its business goals within the scope of this position. This role will contribute to regulatory affairs strategy development, exhibit strong cross functional influencing skills, lead initiatives and provide regulatory expertise. This position may have direct reports.
Coordinate, prepare, and execute premarket applications to FDA, EU and international regulators with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.)Act as liaison with FDA, notified bodies, and international regulators regarding product submissions.
Prepare submission strategy for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.
Proactively lead regulatory efforts required to comply with new regulations and requirements; i.e., EU MDR, MDSAP.
Provide RA leadership within the RA organization.
Review protocols and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Develop or provide input to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
Work cross-functionally and lead cross-functional teams to in preparation of product submissions
Remain current on standards, guidances, and regulations affecting BD; assess and communicate potential impact.
Identify ways to improve the efficiency of current work process and execute them.
Performs other duties and assignments as required.
Professional Skills & Key Competencies
Read, analyze, and interpret, and review scientific, technical, and regulatory literature and documents.
Effectively communicate information to peers and all levels of management.
Translate regulations and guidelines into terms that other functions can understand and apply.
Define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences.
Solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.
Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.
Strong influencing skills. Establishes process and provides expertise for a specific area.
May supervise small staff.
Bachelor's degree, preferably master's degree in life sciences,
Minimum 5 years of strong Regulatory Affairs experience in the medical device industry.
Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle.
Sound understanding of design control processes, FDA, and global regulations and standards.
Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.
Excellent interpersonal, communication and analytical skills.
Knowledge of software and instrument design regulations and standards.
Familiarity with infusion pumps, safety assurance cases, human factors, and cybersecurity.
Any Additional Information
REMOTE or San Diego, CA based
If Remote - Ability to travel up to 30% (when travel is able to resume safely)
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, or any other protected status.
Primary Work Location
USA CA - San Diego TC Bldg C&D
BD (Becton, Dickinson And Company)