BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Franklin Lakes, New Jersey
Job Description SummaryMaintains regulatory documentation and works with project teams to provide ongoing regulatory support. Develops regulatory strategy for product submissions and regulatory compliance activities. Develops and maintains domestic and international submissions and documentation. Reviews international and domestic labeling, marketing communications and product design documentation ensuring compliance with regulatory requirements. Provides regulatory guidance.
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.
Maintains Technical Documentation to support CE Marking of products.
Assists with Notifications of Change to the Notified Body as required.
Assists in the preparation of Business Unit procedures to ensure compliance with Regulatory and business requirements.
Provides information to regional RA employees for the registration of products with foreign regulatory agencies, on assignment.
Assist with RA projects and related tasks as requested.
Maintains budget records and provides monthly updates of the status.
Maintains regulatory databases/filing of regulatory documentation including: regulatory strategies, change notifications and responses, letters-to-file, etc.
Assists in the compilation/assembly of RA submissions as needed.
Prepares, submits and maintains 510(k)s, technical files and international regulatory submissions.
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 guidance as needed.
The qualifications below should be considered minimum 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 in a technical and or science discipline with a minimum of 1 year related professional experience or equivalent combination of education and experience.
Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications. Good prioritizing, organization, interpersonal, communication and analytical skills. Knowledge of software, instrument and disposable design practices. Knowledge of ISO / MDD and Canadian regulatory requirements. Ability to influence and work with personnel at all levels and functional boundaries. Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.)
SPECIFIC SKILLS & ABILITIES
Language Skills: Ability to read, analyze, and interpret regulatory literature and documents. Ability to format regulatory submissions that conform to prescribed style and format. Ability to effectively communicate information to peers and management. Ability to translate regulations and guidelines into terms that employees can understand.
Mathematical Skills: Ability to calculate figures and amount such as proportions, percentages etc.
Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions, furnish in written oral, diagram, or schedule form.
Primary Work LocationUSA NJ - Franklin Lakes
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