Regulatory Affairs Specialist I (Hybrid)

Job Description Summary

This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week. Office location is Covington, Georgia.

Job Description

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 creativity 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 ground-breaking 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.

SUMMARY

The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.

This position works closely with the RA Leadership Team,.

*This position does not offer relocation assistance*

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

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

Provide technical collaborate with FDA and international reviewers and respond to questions

Provide timely review and approval of product labeling and marketing claims for regulatory compliance

Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations

May provide direction of other personnel to accomplish duties

QUALIFICATIONS:

Knowledge of the U.S. and European medical device regulations preferred

Must have excellent written and verbal communication skills

Must be self-motivated by working independently and having the ability to take ownership of their responsibilities

Must be able to prioritize and handle several projects concurrently

Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience

Must be able to provide leadership and mentoring skills to less expert regulatory personnel

Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

EDUCATION and/or EXPERIENCE :

BS in a scientific field with 1+ years employment in the areas of medical device product registration, compliance or quality systems; or

Regulatory Affairs Certification (RAC) desired

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 encourages you to bring your authentic self to work. It’s also a place where we help each other be phenomenal, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally hard-working and committed to encouraging an inclusive, growth-centered, and exciting culture. You will have the opportunity to help craft the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the creativity and aim to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

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.

PDN

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Primary Work Location

USA GA - Covington BMD

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.