BD (Becton, Dickinson and Company) Senior RA Specialist in San Diego, California
Job Description SummaryJob requires working knowledge of FDA regulation of software and develops regulatory strategies for product submissions and regulatory compliance activities based on applicable standards, guidance and policy docuemnts. Develops and maintains domestic and international submissions. Reviews international and domestic labeling, marketing communications and product design documentation ensuring compliance with regulatory requirements. Provides regulatory guidance to the business and other functions to ensure understanding of the regulatory strategy.
This job description does not promise or imply that the functions & responsibilities listed are the only duties or responsibilities to be performed or that the position may not change or be eliminated. Employees are always expected to follow their supervisors' instructions and to perform the tasks requested by their supervisors.
Develops global regulatory strategies for both regulated and unregulated software applications as well as electromechanical and other types of devices.
Prepares, submits and maintains 510(k)s, technical files and international regulatory submissions.
Participate as a core team member for development projects.
Reviews product design and change documentation.
Reviews domestic and international labeling for compliance to labeling requirements, including content, format, 510(k) and regulatory registration impact, etc.
Provides regulatory review and approval for domestic and International product marketing communications.
Provides regulatory guidance as needed.
Experience with sterile disposable products. Familiar with product biocompatibility, sterilization and packaging requirements
SPECIFIC SKILLS & ABILITIES
Ability to read, analyze, and interpret regulatory literature and documents.
Ability to format regulatory submissions that conform to prescribed style and format and ensure content is complete.
Ability to effectively communicate information to peers and management. Ability to translate regulations and guidelines into terms that other functions can understand.
Ability to define problems, collect data, establish facts, and draw valid conclusions, and then communicate the information both verbally and in writing to a variety of audiences.
Ability to 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.
Below are the minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level and company need.
Bachelor’s degree, preferably in the life sciences, and minimum of 3-5 years related professional experience.
Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications.
Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle.
Ability to prioritize effectively and organize complex information.
Excellent interpersonal, communication and analytical skills.
Knowledge of software, instrument and disposable design regulations. Knowledge of ISO / MDD and Canadian regulatory requirements.
Ability to collaborate effectively with personnel at all levels and functional boundaries. Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.).
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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.