Regulatory Affairs Consultant

2 weeks ago

Irvine, California, United States Inari Medical Full time


The Regulatory Affairs Specialist operates with a degree of autonomy, providing support to interdisciplinary teams in the formulation and implementation of regulatory strategies for innovative devices and modifications.

Key Responsibilities
  • Act as the regulatory liaison for cross-functional project teams.
  • Develop and implement regulatory strategies for new product initiatives and device modifications, which includes identifying regulatory challenges, monitoring timelines and submission requirements, and formulating contingency plans.
  • Assist the Regulatory Affairs department in the evaluation and authorization of change orders, including drafting letters to file when necessary.
  • Secure market clearance and approvals for class II and III medical devices, including but not limited to 510(k)s, IDEs, pre-submissions, and PMAs.
  • Generate and assess project deliverables for regulatory submissions.
  • Engage with regulatory authorities for initial submissions and to resolve inquiries.
  • Review and endorse device labeling and marketing materials.
  • Maintain and support existing product lines.
  • Contribute to quality system modifications, enhancements, and audits as required.
  • Establish and uphold regulatory procedures.
  • Help keep the organization updated on current and upcoming regulatory requirements.
  • Provide support to the OUS Regulatory team as necessary.
  • Perform additional tasks as assigned.
Qualifications
  • Bachelor's degree in life sciences, engineering, or a related discipline is preferred.
  • A minimum of 2 years of experience in regulatory affairs for medical devices or a relevant field with a Bachelor's degree, or at least 1 year of experience with an advanced degree.
  • Detail-oriented with strong writing and analytical capabilities.
  • Exceptional interpersonal, verbal, and written communication skills.
  • Proficient in Microsoft Office Suite, including Word, PowerPoint, and Excel.
  • Ability to interpret complex regulatory aspects with a comprehensive understanding of various regulations.
Preferred Qualifications
  • Regulatory Affairs Certification is preferred.
Inari Medical provides competitive health and financial benefits for its employees. The compensation range for this role is $75,000 - $90,000, influenced by factors such as location, skills, and experience. Actual compensation may vary.

Inari Medical, Inc. informs applicants that employment is contingent upon the successful completion of a background check.

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