Regulatory Affairs Specialist Job at Katalyst HealthCares and Life Sciences, Tampa, FL

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  • Katalyst HealthCares and Life Sciences
  • Tampa, FL

Job Description

Responsibilities:
  • Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.
  • Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.
  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
  • Evaluate the risk of proposed regulatory strategies; may offer solutions.
  • Reviews proposed labeling for compliance with applicable US and international regulations.
  • Writes/manages the development of package inserts.
  • Reviews and evaluates promotion and advertising material for compliance with applicable regulations.
  • Reviews proposed product changes for impact on regulatory status of the product.
  • Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.
  • Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.
  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
  • Expected Areas of Competence.
  • Demonstrated strong writing and communication skills.
  • Strong attention to detail, ability to multi-task.
  • Knowledge of overall business environment, the orthopedic industry, and the marketplace.
  • bility to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products.
  • bility to function well as a member of the team and build relationships between RA and other areas of the organization.
  • ble to identify risk in Regulatory strategies.
  • Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred.
  • Basic computer skills, including Microsoft Office Suite.
Requirements:
  • US bachelor's degree in life sciences, technical (engineering) or related field (or non-US equivalent).
  • minimum of 3 years' experience in Regulatory Affairs
  • dvanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred.
  • Regulatory Affairs Certification (US or EU) preferred.
  • combination of education and experience may be considered.
Katalyst HealthCares and Life Sciences

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