Job Description SummaryInternational Regulatory Affairs Specialist # Job Description 1. Establish and maintain contact with each worldwide region Regulatory contact in order to: + Negotiate and establish international product submissions (new registrations and re-registrations) that are aligned with that region’s/country’s and the business units integrated Regulatory Affairs Operating Plan (iRAOP) and Annual Strategic Review (ASR) plans. + Monitor, track and report back to the Director, Regulatory Affairs the progress on international product registrations for BD products. + Track and report back to the Regulatory Affairs team the minimum registration requirements for the regions/countries. 2. To manage the iRAOP, including the coordination and chairing of iRAOP calls with the regions/countries. 3. To manage and coordinate the electronic Global Product Submission (eGPS) database to: + Ensure that the most recent, reliable source documents for product registrations are linked, scanned and/or uploaded into the database. + Respond to and track the additional information requests (AIRs) submitted by the international Regulatory Affairs partners. + To provide training as a Super User. 4. Develop and maintain departmental procedures (SOP's and work instructions) for international product registrations. 5. Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary 6. Interface with OEMs to collect specific registration information 7. Coordinate timely preparation of request for Certificates to Foreign Government, Certificates of Manufacture and Free Sales, and Certificates of Exportability. 8. Interface with applicable regulatory agencies and international consulates 9. Attend Professional and industry regulatory meetings to maintain current knowledge of worldwide regulations and international requirements. 10. Collaborate with international regulatory partners to maintain and update Global regulatory registration information In addition to the above responsibilities this position will be responsible for: + Partnering with BD Regulatory Affairs on New Product Development activities, as well as with the International Regulatory Affairs Associates outside of the US are met. + Monitoring and assessing the impact of existing, modified and new international standards and regulations impacting BD DC products (such as EUMDR) Involves using tools and databases such as for regulatory intelligence. + Supporting impact assessments and follow-up for completion of product changes (i.e. Product Requirements Planning (PRP) and/or Assessment of Change Requests (ACR)) for outside US markets. + Leading or participating in Efficiency Projects and other Special Assignments. + Supporting international tender responses requiring product registration related information. Minimum Qualifications + Bachelors Degree in a Technical Discipline + Degree in Regulatory Affairs (preferred) + Some international regulatory experience is highly desirable # Primary Work LocationUSA NJ - Franklin Lakes # Additional Locations # Work Shift 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.