BD

Regulatory Affairs Manager

BD

full-time

Posted on:

Location Type: Hybrid

Location: Covington • United States

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About the role

  • 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.
  • 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).

Requirements

  • Bachelor's degree in a scientific, engineering, or related field; advanced degree (Master's or Ph.D.) preferred.
  • Minimum of 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).
  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving abilities.
  • RAC (Regulatory Affairs Certification) preferred.
  • Proficiency in Microsoft Office Suite and regulatory submission software.
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible working arrangements
  • Professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategiesregulatory filingsregulatory assessmentsregulatory approvalsglobal medical device regulationsquality management systemsanalytical skillsproblem-solving skills
Soft Skills
communication skillscross-functional collaboration
Certifications
Regulatory Affairs Certification