Senior Regulatory Affairs Specialist Job at cGxPServe, Westminster, CO

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  • cGxPServe
  • Westminster, CO

Job Description

Responsibilities:
  • Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to file, and Tech Docs).
  • Provide regulatory direction to development project teams as a core team member.
  • Develop regulatory strategy for new products, evaluating risk of proposed strategies and offering solutions.
  • Review proposed labelling for compliance with applicable global regulations.
  • Review proposed product changes for impact on regulatory status of the products.
  • Contribute to the development and maintenance of Instructions for Use and Surgical Technique Guides.
  • Review and evaluate promotion and advertising material for compliance with applicable regulations.
  • Communicate with regulatory and governmental agencies.
  • May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
  • Support additional regulatory compliance items as required by regulations and as needed by the RA team.
  • May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
Requirements:
  • Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
  • (Preferred) Minimum of 2 years of experience in orthopaedic or medical device industry.
  • (Required) A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
  • Combination of education and experience may be considered.
  • Strong writing, communication, and interpersonal skills.
  • Strong attention to detail.
  • Able to multi-task and balance competing priorities, and willingness to work with changing priorities.
  • Knowledge of overall business environment, ideally within the orthopedic industry.
  • Eager to build relationships between Regulatory Affairs and other teams within the organization.
  • Ability to communicate effectively at all levels.
  • Advanced knowledge of FDA, EU, and other regulatory body regulations.

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