BD (Becton, Dickinson and Company) International Regulatory Affairs Specialist in Franklin Lakes, New Jersey
Job Description SummaryThis position is responsible for the preparation of International regulatory submissions required to market new or modified medical devices in Outside of the US (OUS). Requires the analysis of data, problem solving analysis and in depth evaluations of various factors. May provide leadership by assigning work and resolving complex problems.
Coordinate, prepare, and follow up with OUS submissions in a timely manner.
Act as liaison with regions and Business group to acquire required documentation for submission.
Work with OUS to support registrations/amendments due to proposed device changes.
Prepare/support regional submissions with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
Represent RA in product life cycle development teams by reviewing, approving, and providing input to project teams as to the impact of regional registrations.
Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
Represent RA in design teams and projects by providing regulatory guidance during the product development cycle and coordinating team inputs for OUS submissions.
Support International Registrations as it relates to product changes and/or new product launches.
Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.
B.S. degree or higher preferred or 3 years working experience in Regulatory Affairs
RAPS Certification preferred
International medical device registration experience preferred.
Primary Work LocationUSA NJ - Franklin Lakes
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