Regulatory Affairs Specialist II; hybrid

Position: Regulatory Affairs Specialist II (hybrid)
We are the people who give possibilities purposeBD 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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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.

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 training or direction to other regulatory team members

QUALIFICATIONS:

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 documentationEDUCATION and/or

EXPERIENCE:

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 equivalent2 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) desiredLANGUAGE

SKILLS:

Must have command of the English language MATHEMATICAL

SKILLS:

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

Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentationPHYSICAL DEMANDS:

Must be able to operate computer and office equipment as needed

Must be able to travel via airlines as neededWORK ENVIRONMENT:

Traditional office environment

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective…