Hybrid Regulatory Affairs Specialist II - 4 On-Site Days

BD; Covington (GA); Hybrid; USD 85,000 - 110,000; Full time

Job summary

BD in Covington, GA is seeking a Regulatory Affairs Specialist II to drive regulatory strategies for medical devices across US and international submissions. You will develop timelines, prepare submissions, and collaborate with cross-functional teams to ensure regulatory compliance throughout product life cycles.

The ideal candidate has BS in a science field with 2–5 years in medical device registration, strong writing skills, and experience with 510(k), IDEs, PMAs or international submissions,

Qualifications

• BS in a scientific field with 3–5 years in medical device product registration.
• 2+ years regulatory support through the product life cycle on 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
• CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
• Regulatory Affairs Certification (RAC) desired
• Must have command of the English language
• Mathematical skills commensurate with educational background for summarizing data
• Ability to plan and complete regulatory pathway determinations
• Must travel via airlines as needed
• Traditional office environment

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
• May provide training or direction to other regulatory team members

Skills

Regulatory knowledge

Communication

Independent work

Project prioritization

Technical writing

Leadership

Confidentiality

Education

BS in science

RAC desired

Job description

BD in Covington, GA is seeking a Regulatory Affairs Specialist II to drive regulatory strategies for medical devices across US and international submissions. You will develop timelines, prepare submissions, and collaborate with cross-functional teams to ensure regulatory compliance throughout product life cycles.

The ideal candidate has BS in a science field with 2–5 years in medical device registration, strong writing skills, and experience with 510(k), IDEs, PMAs or international submissions,