Staff Regulatory Affairs Specialist (REMOTE)

Company: Becton Dickinson
Location: San Diego
Posted on: June 25, 2022

Job Description:

Responsibilities Job Description SummaryThe Staff Regulatory Affairs (RA) Specialist will represent Regulatory Affairs within WWIPD 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. Job Description Be part of something bigger 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. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Duties and Responsibilities: The Staff RA 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 leads multiple long-term projects with some direction/support from supervisor. Interacts with supervisor as required on activities, issues, or turning points. 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 WWIPD 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, and associated devices. SPECIFIC SKILLS & ABILITIES: Ability to read, analyze, and interpret regulatory literature and documents. 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. Ability to function under change. MINIMUM QUALIFICATIONS: 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 years related professional experience. Solid understanding and experience with current FDA medical device regulatory requirements (e.g. 510k), ISO standards related to the Medical Devices, EU MDD & MDR requirements and country specific requirements where business group's products are marketed. Strong background and history of representing RA in cross functional projects with consistent record of successful outcomes. Ability to prioritize optimally and coordinate sophisticated information. Excellent interpersonal, communication and analytical skills. Knowledge of Medical Device and disposable design regulations. Ability to collaborate optimally with personnel at all levels and functional boundaries. Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit https://jobs.bd.com/ 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. PDN LI-PRO Primary Work LocationUSA CA - San Diego TC Bldg C&D Additional Locations Work Shift Apply Save Job PDN-968d01da-cb46-41e6-bcad-5211d165c5f8

Keywords: Becton Dickinson, San Diego , Staff Regulatory Affairs Specialist (REMOTE), Other , San Diego, California