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Regulatory Affairs International Specialist I
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.
The Regulatory Affairs International Specialist I is responsible for providing technical direction to complete the following:
- International submissions (new international registrations, renewals and re-registrations, New Product Dossiers, International Dossiers, etc.)
- Provide response to requests from BD International Business Centers (IBC’s) and customers in support of new product registrations, design changes, bids/tenders, etc.
- Maintenance of existing product licenses and the international databases
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following.
- Provide international regulatory support through the product life cycle on product project teams (e.g., collaboratively develop international regulatory strategies, timeline development, change control and preparing submission related documents)
- Coordinate requirements beyond the requirements and standard content of the Technical File/Design Dossier (i.e., compliance with non-MDD directives and Competent Authority notifications).
- Coordinate the generation of International Dossiers for international product registration for new and legacy projects. Prepare the International Dossier and other related information for BD IBC’s. Respond to inquiries from BD IBC’s to facilitate new product registration, design change notifications, license renewals, re-registrations, and international marketing bid/tenders.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
- Participate in projects related to international labeling requirements.
- Research and respond to regulatory questions received from other division functions, international regulatory groups and outside sources (i.e., customs clearance)
- Implement and maintain divisional and corporate international regulatory procedures (i.e., R-017 International Change Notifications).
- Provide and/or coordinate International RA approval of Distribution Designation Forms (DDF).
- Coordinate response to questions from international ministries of health.
- Participate and/or manage operations projects as needed.
- Research and document relevant new or updated international RA regulations.
- Preform other duties as assigned.
- Must have knowledge of US, EU MDD/MDR, AIMDD and other international regulatory requirements such as Japan, Canada, Australia, LATAM, APAC and ASEAN
- Must be proficient with the FDA CECATS process
- Strong verbal and written communication skills with ability to optimally communicate at multiple levels in the organization
- Must be proficient with MS Office and Adobe PDF creation
- Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
- Must be able to prioritize and handle several projects concurrently
- Must be self-motivated by working independently and having the ability to take ownership of their responsibilities
- Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
- Must be able to meet goals on time
EDUCATION and/or EXPERIENCE:
- BS/BA in a scientific discipline with 1-3 years employment in the areas of project registration, compliance or quality systems; or Combination of education and experience determined to be equivalent
- Regulatory Affairs Certification (RAC) desired
- Written/Spoken Chinese and/or Mandarin a plus
- Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions
- Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation
- Must be able to operate computer and office equipment as needed
- Ability to travel approximately 5%, including internationally.
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.
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Job posted: 2022-07-08