Senior Regulatory Affairs Specialist
Holaira, Inc. - Plymouth, MN

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Position Summary:

The Senior Regulatory Affairs Specialist will be responsible for supporting international and US regulatory submissions. Specifically, this position will be responsible for managing international submissions directly or through contract organizations and managing various sections of US IDE submissions. Additionally, this position will support the R&D group in assessing changes and impacts.
Duties for this position support research and development, preclinical, clinical, and manufacturing.

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.
  • Proficiency with MS Word, PowerPoint and Excel
  • Excellent verbal and written communication skills.
  • Ability to work effectively in cross-functional team.

Preferred Qualifications: (Optional)

  • Experience working with PMAs and novel devices.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.


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