Lead Regulatory Affairs Consultant

4 weeks ago

Canada Shockwave Medical, Inc. Full time $92,000 - $134,000

Position Overview:

Company: Shockwave Medical, Inc.

Location: Hybrid Remote

Role: Senior Regulatory Affairs Consultant

Overview:
Shockwave Medical, Inc. is at the forefront of innovation in the field of Intravascular Lithotripsy (IVL), dedicated to addressing complex calcified cardiovascular conditions. The organization strives to redefine the standard of care for medical device interventions in atherosclerotic cardiovascular disease through its pioneering approach of utilizing localized sonic pressure waves to effectively manage calcified plaque.

  • Engage with cross-functional teams to ensure compliance with regulatory standards in a timely manner.
  • Serve as a key decision-maker on regulatory matters under the supervision of Regulatory Affairs Leadership.
  • Formulate regulatory strategies that align with organizational objectives.
  • Provide regulatory insights to product development and operational teams.
  • Review and endorse documentation for regulatory submissions.
  • Compile and submit regulatory filings punctually in both domestic and international markets.
  • Maintain up-to-date regulatory policies and procedures.
  • Facilitate effective communication with internal stakeholders and regulatory bodies.
  • Assess the regulatory implications of design, clinical, and manufacturing modifications.
  • Support quality management systems and audits.
  • Draft and refine technical documentation.
  • Plan and oversee project timelines and deliverables.
  • Offer guidance on data development for regulatory submissions.

Qualifications:

  • At least 5 years of experience in regulatory affairs within the medical device sector.
  • Bachelor's degree in a relevant discipline; PhD is preferred.
  • Familiarity with both domestic and international regulatory frameworks.
  • Experience with medical device submissions, including 510(k), IDE, PMA, etc.
  • Capability to devise regulatory strategies that align with compliance requirements and business objectives.
  • Strong organizational and multitasking abilities.
  • Proficiency in Microsoft Word, Excel, Adobe, and PowerPoint.
  • A background in medical device software engineering is advantageous.

Compensation and Benefits:

  • Comprehensive Medical, Dental, and Vision coverage.
  • 401k plan options with employer matching.
  • Short-Term and Long-Term Disability Insurance, along with Life Insurance.
  • Employer contributions towards Health Savings Accounts (HSA).
  • Competitive Paid Time Off (PTO) policy.

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