BD Nogales Norte
Regulatory Affairs Specialist I (Hybrid)
BD Nogales Norte, Covington, Georgia, United States, 30209
Regulatory Affairs Specialist I (Hybrid)
Join to apply for the
Regulatory Affairs Specialist I (Hybrid)
role at
BD Nogales Norte
Be among the first 25 applicants (3 days ago)
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description Summary We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities
Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required
Collaborate with FDA and international reviewers and respond to questions
Review and approve product labeling and marketing claims for regulatory compliance
Support CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
Minimum Requirements
BS in a scientific field with 1+ years employment in medical device product registration, compliance or quality systems; or equivalent combination of education and experience
Regulatory Affairs Certification (RAC) desired
Knowledge of the U.S. and European medical device regulations preferred
Maintain confidentiality in dealing with regulatory and clinical documentation
Excellent written and verbal communication skills
Preferred Requirements
Self‑motivated, able to work independently and take ownership of responsibilities
Ability to prioritize and handle several projects concurrently
Technical writing skills and proficiency at compiling successful submissions for the appropriate audience
Workplace Information For most roles, we require a minimum of 4 days of in-office presence per week. Remote or field-based positions will have different arrangements indicated in the posting.
Employment is contingent upon the Company’s receipt of sufficient proof of vaccination against COVID‑19. Consistent with BD’s Workplace Accommodations Policy, accommodation requests will be considered pursuant to applicable law.
Why Join Us? At BD, you’ll discover a culture where you can learn, grow, and thrive. We value your opinions, encourage authentic contributions, and hold each other accountable. We are committed to innovation and improving health worldwide. To learn more, visit https://bd.com/careers.
EEO Statement Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
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Regulatory Affairs Specialist I (Hybrid)
role at
BD Nogales Norte
Be among the first 25 applicants (3 days ago)
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description Summary We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities
Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required
Collaborate with FDA and international reviewers and respond to questions
Review and approve product labeling and marketing claims for regulatory compliance
Support CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
Minimum Requirements
BS in a scientific field with 1+ years employment in medical device product registration, compliance or quality systems; or equivalent combination of education and experience
Regulatory Affairs Certification (RAC) desired
Knowledge of the U.S. and European medical device regulations preferred
Maintain confidentiality in dealing with regulatory and clinical documentation
Excellent written and verbal communication skills
Preferred Requirements
Self‑motivated, able to work independently and take ownership of responsibilities
Ability to prioritize and handle several projects concurrently
Technical writing skills and proficiency at compiling successful submissions for the appropriate audience
Workplace Information For most roles, we require a minimum of 4 days of in-office presence per week. Remote or field-based positions will have different arrangements indicated in the posting.
Employment is contingent upon the Company’s receipt of sufficient proof of vaccination against COVID‑19. Consistent with BD’s Workplace Accommodations Policy, accommodation requests will be considered pursuant to applicable law.
Why Join Us? At BD, you’ll discover a culture where you can learn, grow, and thrive. We value your opinions, encourage authentic contributions, and hold each other accountable. We are committed to innovation and improving health worldwide. To learn more, visit https://bd.com/careers.
EEO Statement Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
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