Regulatory Affairs Specialist II; hybrid

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Job Description
*** This role provides flexibility to work 4 days on site and Friday remotely on a weekly basis in Covington, GA.
*** Job Description

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

• 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 training or direction to other regulatory team members

• Must have knowledge of the U.S. and European medical device regulations
• Must have excellent written and verbal communication skills
• Must be self-motivated by working independently and having the ability to take ownership of her/his 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 experienced regulatory personnel
• Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

• BS in a scientific field with 3-5 years employment in the areas of medical device product registration.
• Combination of education and experience determined to be equivalent
• 2 or more years 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)
• Experience preparing and auditing 510(k) s, IDEs, PMA and/or international submissions
• Experience reviewing and approving product labeling and marketing claims for regulatory compliance
• Supporting CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
• Previous experience training or direction to other regulatory team members
• Regulatory Affairs Certification (RAC) desired

• Must have command of the English language

• Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions

• Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation

• Must be able to operate computer and office equipment as needed
• Must be able to travel via airlines as needed

• Traditional office environment

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare…