Job Description: Summary
The Staff RA specialist will represent Regulatory Affairs within WW Infusion Specialty Disposables (WWISD) platform of the Medication Delivery Solutions business unit of Becton Dickinson (BD) on new product development, product engineering, and other product development initiatives and maintenance activities.
The Staff Regulatory Affairs Specialist will act as the Regulatory lead on cross-functional product development teams to achieve business goals.
Provide teams with strategic and tactical guidance regarding global regulatory requirements to support product approvals/registrations.
Independently manages multiple long-term projects with direction/support from supervisor. Interacts with supervisor as required on activities, issues, or milestones. Inspires effective unit dynamics and imparts a sense of commitment to unit goals. Encourages and empowers others to achieve outcomes.
Develops global regulatory strategies for WWISD products.
Prepares, submits and maintains 510(k)s, technical files and international regulatory submissions.
Reviews product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
Reviews labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc.
Provides regulatory review and approval for product marketing communications.
Provides regulatory guidance to functional teams and business leaders as needed.
Understanding of regulations for sterile disposable products.
Familiar with product biocompatibility, sterilization and packaging requirements.
Working knowledge of regulations for infusion pump sets, gravity IV sets and associated devices.
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.
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.
Strong working knowledge and experience with current FDA medical device regulatory requirements, EU MDD & MDR requirements and country specific requirements where WWISD products are marketed.
Basic understanding of drug regulations to support the IV Fluid platform with the business unit.
Strong background and history of managing projects with proven track record of successful outcomes.
Ability to prioritize effectively and organize complex information.
Excellent interpersonal, communication and analytical skills.
Knowledge of 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.).
This position is through 9/30/2020. This position works closely with the RA Leadership Team, and our hope is the candidate would find a long-term position within BDX.
Primary Work Location
USA CA - San Diego TC Bldg C&D
USA CA Brea, USA NJ - Franklin Lakes
1st Shift 8am-430pm (United States of America)
BD (Becton, Dickinson And Company)