Staff Regulatory Affairs Specialist (hybrid)

Posted 10 June 2022
SalaryUS$120000 - US$140000 per annum + bonus, benefits, RSU
LocationCarlsbad
Job type Permanent
DisciplineLife Sciences
ReferenceBBBH134607_1654886156
Contact NameMelody Lam

Job description

The Staff Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; 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. Independently determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
  • Prepares regulatory submissions including 510(k) premarket notifications for US FDA.
  • Prepares regulatory submissions including technical files/design dossiers for registration of products in European Union and interfaces as needed with Notified Bodies regarding significant changes to products.
  • Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information.
  • Assists with post market surveillance evaluation, trending, and reporting including updates to risk management (e.g., 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.
  • Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.
  • Maintains FDA establishment listings and registration.
  • Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, MDD 93/42/EEC, MDR 2017/745, 21 CFR 820, global medical device registration, technical writing, and external standards.
  • Other duties as assigned


Requirements

  • Typically requires a bachelor's degree and five years of experience in the medical device industry.
  • Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, MDD 93/42/EEC, and MDR 2017/745.
  • Orthopaedic or spine experience preferred.
  • RAC certification preferred.
  • Must have 510(k) submission experience.
  • Must be detail oriented and possess strong technical writing skills.
  • Must possess strong interpersonal communication, teamwork and organizational skills.