BD (Becton, Dickinson and Company) Senior Manager, Regulatory Affairs in San Diego, California
Job Description SummaryThis position focuses on the implementation of Regulatory Affairs (RA) procedures related to multiple projects, with a focus on EU MDR implementation and ongoing compliance with CE Marking requirements. This position may also supervise other regulatory affairs personnel.
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.
Serves as RA representative on project teams, or manages direct reports serving on teams.
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.
Reviews product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
Reviews domestic and international labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc.
Provides regulatory review and approval for domestic and International product marketing communications.
Provides regulatory guidance to functional teams and business leaders as needed.
Participates as an alternate in quality system audits and inspections, and directly interacts with Notified Body personnel to ensure ongoing compliance with EU MDD and MDR requirements.
Understanding of regulations for sterile disposable products.
Familiar with product biocompatibility, sterilization and packaging requirements.
Working knowledge of regulations for infusion pumps 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 7-9 years related professional experience.
Strong working knowledge and experience with current FDA medical device regulatory requirements and EU MDD & MDR requirements.
Strong background and history of managing projects and/or individuals, with proven track record of successful outcomes.
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.).
Regulatory Affairs Professional Society (RAPS) certification,
Experience working in a multi-level corporate environment typical of large corporations.
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