Regulatory Affairs Specialist

Posted 21 September 2022
Salary US$100000 - US$110000 per annum
Job type Permanent
DisciplineLife Sciences
Contact NameSophia Ondi

Job description


Essential Functions:

  • Prepares and submits product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
  • Maintains company registrations and device listings in the US, Canada, EU, and other countries.
  • Maintains knowledge on current regulations and guidelines.
  • Evaluates compliance with applicable regulations, project policies, and procedures
  • Reviews and writes standard operating procedures (SOPs) and other RA policies as necessary.
  • Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
  • Coordinates with international regulatory team members regarding product change and regulatory notification and/or approval requirements.
  • Serves as subject matter expert for Regulatory Affairs.
  • Provides management with ideas for developing and implementing strategies and processes.
  • Analyzes advertisements, labels, and public communication documents for regulatory compliance.
  • Reports significant regulatory issues related to a product's release to appropriate parties.
  • Evaluates product compliance to applicable regulations and project requirements.
  • Participates and assists with FDA facility inspection, notified body audits, and other government inspections as needed.
  • Performs other related duties and projects as business needs require at direction of management.

Education and Experience:

  • Bachelor's degree in related field preferred.
  • Minimum 1 year of experience in Regulatory Affairs.
  • Previous SaMD (software as a medical device) experience required.

Knowledge and Abilities:

  • Proficient knowledge of general office procedures.
  • Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
  • Proficient quantitative and analytical skills.
  • Demonstrated prioritization and time management skills.
  • Demonstrated negotiation abilities.
  • Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
  • Demonstrated high standard of quality of work.
  • Demonstrated knowledge of FDA 510K and ISO 13485 Standards.
  • Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
  • Demonstrated reliability, dependability, and flexibility in work habits.
  • Demonstrated attention to detail and accuracy.
  • Ability to analyze and collate data for presentations and reports.
  • Ability to prioritize and organize project tasks and goals effectively.
  • Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
  • Ability to interpret and collate data to present an accurate picture of market potential.
  • Ability to research new and emerging technologies and practices.