Regulatory Affairs, Specialist I

BD; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

BD is seeking a Regulatory Affairs Specialist I to support regulatory submissions and lifecycle activities for Urology and Critical Care products. You will coordinate US and international submissions, interact with FDA reviewers, and contribute to labeling, compliance, and CE marking efforts.

Ideal candidates hold a BS in a scientific field with 1+ year regulatory experience, strong writing skills, and the ability to manage multiple projects with diligence and accuracy.

Qualifications

• BS in a scientific field; 1+ year in regulatory/quality
• RAC preferred
• Knowledge of US/EU medical device regs preferred
• Confidentiality in regulatory docs
• Excellent written and verbal communication skills

Responsibilities

• Provide regulatory support through product life cycle on project teams
• Prepare and audit 510(k)s, IDEs, PMA and international submissions
• 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 technical files and clinical evaluations

Skills

Regulatory affairs

510(k) submissions

FDA communications

Technical writing

GMP/ISO knowledge

Education

Bachelor's degree in a scientific field

Tools

Regulatory submissions tools

Quality management systems

Job description

We are the people who give possibilities purpose

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

Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.

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

• 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

Minimum Requirements:

• BS in a scientific field with 1+ years employment in the areas of medical device product registration, compliance or quality systems; or Combination of education and experience determined to be equivalent

• 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 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

Why Join Us?

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 imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

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.

Required Skills

Optional Skills

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)