About the role

  • Collaboratively interface with a variety of levels on significant matters, often requiring coordination across organizational units.
  • Outline submission and clearance requirements in assigned geographies.
  • Develop sound regulatory strategies in alignment with business priorities and update strategies based upon regulatory changes.
  • Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
  • Compile, prepare, review, and submit high-quality regulatory submissions to authorities on time in US, EU, and Canada.
  • Interact and negotiate directly with regulatory authorities during development and review processes to ensure clearance/approvals.
  • Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with regulatory requirements.

Requirements

  • 5+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices.
  • Must have experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers.
  • Experience in the use of clinical data to support regulatory submissions.
  • Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus.
  • Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993.
  • Educational background: Bachelor’s degree Engineering/ Life Sciences (advanced degree preferred)
  • RAC certification (U.S. or EU) is a plus.

Benefits

  • medical insurance
  • dental insurance
  • vision insurance
  • 401(k) retirement plan
  • life insurance
  • long-term and short-term disability insurance
  • paid parking/public transportation
  • paid time off
  • paid sick and safe time

Job title

Senior Regulatory Affairs Specialist

Job type

Experience level

Senior

Salary

$93,680 - $140,520 per year

Degree requirement

Bachelor's Degree

Location requirements

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