Regulatory Affairs Specialist II (Hybrid)

Becton Dickinson NA; Covington (GA); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Becton, Dickinson, and Company (BD) in Covington, GA seeks a Regulatory Affairs Specialist II to implement regulatory strategies for US and international submissions. The role involves lifecycle support, labeling reviews, and collaboration with FDA reviewers.

Candidate will prepare regulatory documents, maintain clinical evaluations, and may mentor junior staff. A BS in a scientific field and 3–5 years of device experience are required; RAC is preferred.

Qualifications

• Knowledge of US and European medical device regulations.
• Excellent written and verbal communication.
• Ability to work independently and take ownership of responsibilities.
• Ability to prioritize multiple projects concurrently.
• Strong technical writing skills for submissions.

Responsibilities

• Provide regulatory support across product lifecycle and develop strategies.
• Prepare/audit 510(k)s, IDEs, PMA and international submissions as needed.
• Coordinate with FDA and international reviewers and respond to inquiries.
• Review product labeling and marketing claims for regulatory compliance.
• Support CE marking activities and maintain technical files and clinical evaluations.
• Train or mentor other regulatory team members.

Skills

Regulatory knowledge

Written & verbal communication

Independent working

multitasking

Technical writing

Mentoring

Confidentiality

Education

BS in a scientific field

Regulatory Affairs Certification (RAC) desirable

Job description

Job Description

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

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

• 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 documentation

EDUCATION 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) desired

LANGUAGE 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 submissions

REASONING ABILITY

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

PHYSICAL DEMANDS

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

WORK ENVIRONMENT

• Traditional office environment

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?

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.

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 SkillsOptional Skills.Primary Work LocationUSA GA - Covington BMDAdditional LocationsWork ShiftUS BD 1st Shift 8am-430pm (United States of America)