Regulatory Affairs Specialist I (Hybrid)

BD

85d

About The Position

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.

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

Nice To Haves

• 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

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 collaboration 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

What This Job Offers

• Education Level: Bachelor's degree