Senior Manager / Director of Regulatory Affairs (Aesthetics Injectable)

Senior Manager / Director of Regulatory Affairs (Aesthetics Injectable)

United States

Position Summary:

The Senior Manager/Director of Regulatory Affairs will play a critical role in the development of aesthetics injectable products through balanced compliance and managing of aspects of regulatory activities necessary to maintain and grow our business.

Responsibilities:

  • Participate in activities to ensure compliance with regional regulatory requirements.
  • Provide regulatory support for new product registrations, labeling compliance, regulatory document preparation per various international specific country registration.
  • Develop and manage procedures and systems to perform regulatory operational activities.
  • Develop and implement regulatory strategies for launching new products and maintaining existing products.
  • Keep abreast of new Regulatory changes in all target markets globally and new regulations and guidelines and ensure adherence throughout the product life cycle.
  • Work closely with contractors, distributors and registration agencies to register products for global sales.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
  • Maintain Regulatory filings and Health Authority communications through electronic and paper records in a timely, accurate and efficient manner.
  • Provide input on regional regulatory requirements and standards to ensure that requirements are incorporated in product development.
  • Review and approve product labeling and promotional materials to ensure regulatory compliance.

Requirements:

  • Demonstrated capabilities to be agile and nimble in a start-up organization.
  • Effective communication and a reputation for integrity and ethical behavior are critical.
  • Strong interpersonal skills, a flexible, collaborative, and team-oriented approach to problem-solving, and an ability to work in a fast-paced, rapidly changing environment.
  • 5+ years of aesthetics injectables experience
  • 5+ years of Regulatory Class III/PMA Medical Device experience.
  • Bias towards start-up experience in a fast-paced environment!
  • Strong analytical, problem-solving mindset.
  • Exceptional organizational skills and detail-oriented.
  • Strong written and verbal communicator with key decision-makers.
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