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Senior Regulatory Affairs Specialist (hybrid)

  • Location
  • Job type Permanent
  • Reference BBBH134606
  • Salary US$110000 - US$130000 per annum + bonus, RSU, benefits
  • Specialisation Legal
  • Posted June 10, 2022

*Hybrid on-site/remote position in Carlsbad, CA

The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products, including Software technologies; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.

Essential Duties and Responsibilities

  • Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
  • Supports and assists in FDA (510(k)), EU (MDR) and ROW regulatory submissions for new product approvals involving software.
  • Provides input on domestic and OUS regulatory strategies for products containing software, and software as a medical device (SaMD).
  • Assists regulatory leadership in ensuring IEC 62304 requirements are applied in the development and improvement of the software lifecycle processes for domestic and OUS submissions.
  • Evaluates design changes to products to determine impact to submissions and potential need for additional submissions.
  • Assists with post-market surveillance evaluation, trending, and reporting, including updates to risk management (FMEA) process.
  • Reviews product labeling and promotional materials to ensure consistency with regulatory approvals.
  • Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
  • Provides department support during internal and external audits.
  • Develops and revises department SOPs/SWIs to ensure compliance with applicable global regulatory requirements.
  • Maintains FDA establishment listings and registration.
  • Other duties as assigned.


Requirements

  • Typically requires a bachelor's degree and 2-3 years of experience in the medical device industry.
  • Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, MDD 93/42/EEC, and EU MDR.
  • Orthopaedic or spine experience preferred.
  • RAC Certification is preferred.
  • Must be detail oriented and have strong technical writing skills.
  • Must possess strong interpersonal communication, teamwork and organizational skills.