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The Senior Regulatory Affairs Specialist will be responsible for supporting international and US regulatory submissions.

We have several locations available for this role: NJ, NY, MA, CA, UT, TX, FL, MD, and NC.

Responsibilities:
Key

  • Compile, prepare, review and submit regulatory submissions to FDA and international authorities.
  • Write and edit technical documents to support regulatory submissions.

Strategic

  • Assist in the development of regulatory strategy and update strategy based on regulatory changes.
  • Provide regulatory input to product lifecycle planning.
  • Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
  • Participate in risk-benefit analysis for regulatory compliance.
  • Assist in SOP development and review.

Premarketing

  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Assess acceptability of quality, preclinical and clinical documentation for submissions to comply with regulatory requirements for clinical trials and marketing applications.
  • Monitor impact of changing regulations on submission strategies.
  • Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
  • Create project plans and timelines.

Qualifications:

  • Bachelor’s degree in a scientific or related discipline is highly preferred. Or, equivalent combination of education and experience.
  • Minimum of 5-10 years regulatory affairs experience in a medical device company working with Class II/III medical devices or submissions requiring randomized clinical trials.
  • Experience working with FDA and/or international agencies.
  • Ability to work effectively in cross-functional team.

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