Bausch Health

  • Sr Manager Regulatory Affairs (Aesthetics)

    Location US-WA-Bothell
    Job ID
    10763
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Manager/ Senior Manager Aesthetics, Regulatory Affairs handles all regulatory development aspects of aesthetic devices. The incumbent participates on the product development team to provide regulatory guidance for aesthetic devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned devices and may perform due diligence efforts on new product opportunities.

     

    This position will have direct reports.

    Responsibilities

    • Responsible for developing a global product regulatory strategy
    • Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
    • Develop a product regulatory timeline aligned to product development, with key regulatory milestone, and activities for agency filing
    • Coordinate with the team on the development of product labels
    • Ensure labeling content and product documentation is developed in accordance with regulatory requirements
    • Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
    • Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities
    • Act as a regulatory contact for assigned country Regulatory Authorities 
    • Liaise with country-specific Regulatory Affairs personnel for international submissions and registrations
    • Manage interactions with other (e.g., Quality, Compliance) during Regulatory Authority inspections
    • Provide regulatory guidance/input to  device change control and internal product review boards
    • Manage assigned personnel
    • Other job responsibilities as needed.
    • Key Relationships: 

      Internal Customers/Business Partners:

      Business Senior Leadership
      Quality Assurance
      Research and Development
      Manufacturing Quality Assurance
      Design Quality Assurance
      Global Product Surveillance and Safety
      Commercial Teams
      Compliance Senior Leadership (NA)

      External Customers/Business Partners:

      Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
      MDs/ODs

    Qualifications

    • Knowledge of device  regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations
    • Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices
    • Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
    • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices
    • Ability to influence and partner with cross-functional teams in a global surgical organization
    • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
    • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
    • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
    • Demonstrated ability in analytical reasoning and critical thinking skills
    • Strong capability to contribute and lead a team environment
    • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
    • Excellent communication skills; both oral and written
    • Strong interpersonal skills with the ability to influence others in a positive and effective manner
    • Demonstrated ability to contribute to a continuous learning and process improvement environment
    • Capacity to react quickly and decisively in unexpected situations
    • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
    • Focused ability to influence operational excellence and performance metrics
    • Risk adverse where needed with the ability to identify potential solutions to complex problems
    • 10+ years relevant medical device industry and regulatory experience
    • Aesthetic device regulatory experience highly preferred
    • Bachelor’s degree in science or health related field

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