Job: Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location:

San Diego, CA

Job Information:

The Regulatory Affairs Specialist is an individual with an advanced understanding of medical devices and regulatory submissions processes with the FDA. The Regulatory Affairs Specialist will be responsible for submissions to the FDA and other various Health Authorities, and will advise cross-functional departments during device development stages to comply with regulatory requirements

Responsibilities

  • Provide guidance to cross-functional teams on regulatory requirements, and support product development to comply with requirements
  • Review laboratory protocols, clinical trial reports, manufacturing documents, and controls documents to ensure alignment with regulatory requirements
  • Identify program risks and collaborate with department managers to suggest solutions and improve development strategies and avoid regulatory risks
  • Prepare US FDA submissions, particularly for 510(k) and CLIA Waiver Application submissions
  • Develop and implement strategies for completion of fruitful regulatory submissions
  • Applies FDA regulations to laboratory and business practices
  • Keep current on changing FDA and global regulations
  • Writes and develops package inserts and reviews labeling for compliance of US and international regulations
  • Participate in quality system audits
  • May be involved in training junior regulatory affairs team members, and serving as a liaison with CFDA regulatory affairs specialists

Qualifications

  • B.S or higher in a life sciences or related discipline
  • Regulatory Affairs Certification (US) preferred
  • At least 5 years of experience in a regulatory affairs position, preferably in a medical devices company
  • Proficient knowledge of the general medical devices industry, business environment, and technology
  • Experience with 510(k) and CLIA Wavier Application Pathways with the FDA
  • Advanced knowledge of FDA regulations, and regulations outside of the US, such as the EU and CFDA
  • Exercises good judgement and strong ethics in problem solving and negotiations
  • Ability to lead and motivate a team
  • Exceptional interpersonal and communication skills, both verbally and written
  • Bilingual English/Mandarin preferred
  • Some travel may be required (less than 10% within the US and internationally)