Regulatory Affairs Specialist II (hybrid)



 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.

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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.

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 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 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
• 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
• 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 industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
• 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.
• 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)