BD (Becton, Dickinson and Company) Staff Regulatory Affairs Specialist (Remote) in San Diego, California
Job Description SummaryThe Staff Regulatory Affairs Specialist is responsible for developing strategies for moderately to highly complex submissions to regulatory agencies worldwide, and directly accountable for executing the US and EU registrations. This position is responsible to support new product development, post-market sustaining activities and international registration activities to enable BD Point of Care business objectives. Interprets regulations, guidance documents and standards, and communicates internally with project teams and international regulatory affairs colleagues how these impact BD’s ability to register product(s). Coordinates and support global product registration requests; interfaces with international regulatory affairs and marketing contacts to support regional registration requirements and develops and maintains department procedures for international product registrations. Assembles technical information, in order to fulfill registration requirements.
Duties and Responsibilities:
Manages planning and preparation of regulatory submissions (e.g. 510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports. Ensures regulatory submissions are prepared and processed in a proactive expeditious and timely manner.
Accountable for establishing, maintaining, adjusting and communicating regulatory submission deadlines to ensure that all product-launch related functional area activities can be planned accordingly.
Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to US FDA and international regulatory agencies.
Partners with business leadership to develop, maintain, and execute domestic and international regulatory strategies to ensure the business is positioned to meet strategic corporate goals.
Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders.
Participates on cross-functional product development teams to ensure the business is positioned to meet strategic corporate goals.
Assists in the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market studies in support of US FDA and international regulatory submissions, asrequired.
Develops policies and procedures which provide direction to the business on regulatory processes and requirements in support of product development.
May participate in the regulatory review of labels, labeling, advertising and promotional materials.
Represents the business in interactions with regulatory authorities. Plays a prominent role in complex negotiations regarding clinical and analytical study designs during the product development (pre-submission) phase, as well as the appropriateness of product claims, wording, andinterpretation/presentationof performance during theverification/validation(pre-clearance/approval)phase.
Interprets statutes, regulations, policies and guidance documents for business teams and product development/support teams. Communicates impact to product development, manufacturing, and/or marketing.
Remains current on regulatory issues/trends affecting business unit products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business.
Minimum of 3-5 years of experience in regulatory/quality area for medical device and/or in-vitro diagnostic (IVD) manufacturers.
Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
Demonstrated success preparing, filing, and completing regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation).
Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
Experience analyzing complex issues and formulating cogent approaches to address them.
Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
Experience maintaining confidential information at appropriate levels within an organization.
Direct experience with US Class I, II and/or III medical devices/IVDs
Expertise and experience in US and EU registrations.
Direct experience with broad range of IVD device types
Experience working directly with FDA, notified bodies and/or international health authorities
- Bachelor of Science degree in a technical discipline (e.g., natural science or engineering) or equivalentregulatory/scientificexperience.
Advanced degree (MS, Ph.D., etc.)
RAPS Regulatory Affairs Certification (RAC)
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.
Primary Work LocationUSA CA - San Diego (Diagnostic Sys.)
Work ShiftNA (United States of America)
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.