Regulatory Affairs Manager

A large medical device manufacturing client in Covington, GA is looking to hire a new Regulatory Affairs Manager! This Regulatory Affairs Manager will lead and manage regulatory submissions, approvals, and compliance activities for medical devices . This role ensures that products meet all national and international regulatory requirements, facilitating timely market access and maintaining post-market compliance. We need someone who can work hybrid, onsite

Job Responsibilities

• Develop and execute regulatory strategies for new product introductions and product lifecycle management.
• Prepare, review, and submit regulatory filings (e.g., 510(k), PMA, CE Mark, etc.) to regulatory agencies worldwide.
• Act as the primary liaison with regulatory agencies during pre-submission meetings, reviews, and inspections.
• Interpret and apply complex regulatory requirements to product development, manufacturing, and marketing activities.
• Conduct regulatory assessments for design changes, manufacturing changes, and labeling updates to determine impact and required submissions.
• Manage and maintain regulatory licenses, registrations, and approvals.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, Marketing, and Clinical Affairs.
• Monitor and analyze evolving global regulatory landscapes, assessing potential impacts on products and processes.
• Participate in internal and external audits to ensure compliance with quality system regulations (e.g., ISO 13485, 21 CFR Part 820).
• Develop and deliver regulatory training to internal stakeholders.
  
  

Skills Needed

• Bachelor's degree in a scientific, engineering, or related field; advanced degree (Master's or Ph.D.) preferred.
• At least 5-7 years of experience in Regulatory Affairs within the medical device industry.
• Demonstrated success in preparing and obtaining regulatory approvals (e.g., FDA 510(k), PMA, CE Mark).
• In-depth knowledge of global medical device regulations (e.g., FDA regulations, MDD/MDR, Health Canada, TGA, MHLW).
• Strong understanding of quality management systems (e.g., ISO 13485, 21 CFR Part 820).
• Regulatory Affairs Certification is preferred.
• Proficiency in Microsoft Office Suite and regulatory submission software.
  
  

Salary of $120,000 - $150,000 annually bonus