Regulatory Affairs International Specialist (Onsite/Hybrid)
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.
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 will be an onsite position in Franklin Lakes, NJ working on a hybrid schedule.
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.
Ensure International Regulatory documents are complete, accurate and well maintained
B.S. degree or higher preferred or 3 years working experience in Regulatory Affairs
RAPS Certification preferred
International medical device registration experience preferred.
EU/International Regulatory experience
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.
Primary Work LocationUSA NJ - Franklin Lakes
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Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ