BD (Becton, Dickinson and Company) Associate Director, Regulatory Affairs in San Diego, California
Job Description SummaryAssociate Director, Regulatory Affairs – Point of Care (Assoc. Dir., POC RA) reports directly to the Vice President, Regulatory Affairs for Diagnostic Systems (VP, DS RA). This position provides regulatory leadership to the BD Diagnostic Systems unit as a member of the POC Leadership Team. Contributes to the development of BD’s POC diagnostics platform strategy and operational plans through sound assessments of regulatory pathways and risks. Such assessments may influence the scientific or technical direction of product design and/or development. Directs functional activities designed to achieve rapid worldwide clearance/approval/registration of BD products with desired claims. Represents BD’s POC interests in pivotal interactions/negotiations with U.S. regulatory agencies, and plays an active role in external efforts to develop standards of strategic importance to BD and to influence policy-making bodies.
Partners with Marketing, Business Development, and other business leaders to create unique market entry and sustainability strategies while maintaining strict regulatory compliance. Works with various BD partners in the development of products for use on BD systems. Critical thinking, strategic agility and dealing with ambiguity are key skill sets for this role.
Leads and develops a direct reports towards achieving aggressive business goals. Responsible for regulatory functional excellence, including overall regulatory strategy, operations, and talent management. This position also establishes the regulatory affairs operating plan for the POC portfolio and drives the efficient delivery of high quality regulatory submissions that shorten time to market and provide competitive advantage.
Provides regulatory leadership to BD’s POC platform team. Works closely with leadership team members to ensure alignment of regulatory strategies with business objectives.
Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other global regulatory agencies.
Communicates potential risks and mitigations associated with regulatory strategies to stakeholders.
Represents BD in interactions/negotiations with U.S. regulatory agencies and enables and empowers staff to interact and negotiate with regulators as well.
Represents BD’s POC interests in external activities benefiting BD, including trade associations, professional organizations, and standards development organizations.
Manages and develops a staff carrying out product submission/registration activities. Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives. Aligns right capabilities to challenging tasks and continually monitors and measures with definitive metrics.
Clearly defines and articulates performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.
Proactively promotes inclusion as a critical component of overall talent agenda for their areas of responsibility.
Directs the preparation and filing of premarket submissions (510(k)), de novo submissions, and Technical Files, and the preparation of content for other ex-U.S. registrations.
Monitors global regulatory developments affecting BD’s POC programs and products and communicates emerging opportunities and concerns to stakeholders.
Manages the regulatory review of labels, labeling, and promotional materials and sets policies to ensure consistency in these reviews.
Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.
Designs and implements training on regulatory issues for staff and for business stakeholders (e.g., Marketing, Sales, Medical Affairs, and R&D).
Develops best-in class-functional processes. Ensures functional skills and competencies are reinforced with appropriate tools, templates, and metrics that are integrated into the product development processes.
Always thinks globally and acts locally with cultural sensitivity and organizational savvy.
Continually works and leverages the power of the matrix.
B.S. or B.A. degree in a technical discipline (biology, microbiology, or molecular biology).
RAPS RAC (U.S.) preferred.
Minimum five years of directly related experience in increasingly responsible positions in the IVD/medical device field, and one or more years of management experience. Experience should include demonstrated success in developing systems for preparation and filing of complex IVD or medical device submissions (both US and international), as well as negotiating favorable regulatory strategies and timely approvals.
Primary Work LocationUSA CA - San Diego (Diagnostic Sys.)
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