Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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 with a focus on standards and compliance, audit support, and/or CAPAs. This position will focus on newly released guidances and standards, providing oversight to completion of a gap analysis, and ensuring the standard or guidance is properly implemented. This position will also be responsible for developing procedures and gaining alliance across MMS RA and acting as a Regulatory contact to support audits. This position may participate as the RA representative in CAPA support. Additionally, this position may provide Regulatory guidance to related departments, develop and implement processes and systems, and will stay abreast of global regulations to help MMS achieve its business goals within the scope of this position. Must possess strong cross functional influencing skills.
Coordinate gap analysis and implementation of new or updated standards, guidances, and regulations. .
Represent RA and demonstrate leadership in Audits, CAPAs, and related compliance activities.
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.
Actively assist regulatory efforts required to comply with new regulations and requirements; i.e., EU MDR, MDSAP.
Review protocols and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Write and update 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
Represent BD in relevant external trade organizations and regulatory standards development as necessary to support BD’s continuous product development and compliance efforts.
Remain current on standards and regulations affecting BD products and keep the relevant team and supervisors informed about 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 professional level staff.
Education Qualifications & Previous Experience:
Bachelor’s degree, preferably master’s degree in life sciences,
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.
Desired/Additional Skills & Knowledge:
Familiarity with infusion pumps, safety assurance cases, human factors, and cybersecurity.
Any Additional Information
Ability to travel up to 30%
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.
BD and Covid-19: To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location, but is temporarily remote-based due to Covid-19. Any offer of employment is contingent upon the candidate reporting to work at the site if/when associates are requested to return to the workplace.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Skilled presenter
Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
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