Bausch Health

  • Senior Manager, Regulatory Affairs ( International Medical Devices)

    Job Location US-NJ-Bridgewater
    Job ID
    10771
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Senior Manager International Medical Devices, Regulatory Affairs will lead a cross-functional team to execute technical documentation in compliance with the applicable regulatory requirements and generating submissions as needed to global health authorities/notified bodies to support marketing approvals.

    The primary focus of this position is to facilitate full compliance for multiple products with the Medical Device Directive (MDD) and the new European Union Medical Device Regulation (EU MDR). In this role, the individual will be the recognized expert, managing large projects or processes, with responsibilities that include working with other cross functional areas to identify, modify, or create necessary documentation to meet the EU MDD and/or remediate EU MDD compliant technical files to meet MDR. Additionally, the Sr. Manager will collaborate with global regulatory teams to ensure that the products remain compliant around the world.

     

    Supervise direct reports:  Yes

     

    Scope of Position:  Support all assigned medical device projects across several business units

    Responsibilities

    • Build and maintain a working familiarity and practical understanding of the EU MDD and MDR regulatory requirements as well as applicable requirements from domestic and international agencies/notified bodies.
    • Drive the preparation, publication, quality control, and delivery of technical documentation required for full compliance with the EU MDD or MDR and associated submissions.
    • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
    • Efficiently navigate all internal document management systems to ensure files are accurately maintained.
    • Ensure harmonization and completion of technical documentation, DOC and ERC or GSPR templates, for regulatory compliance.
    • Ensure overall compliance, contributing to multiple project work streams, implementing creative solutions, and completing on-time execution of individual tasks to support project goals.
    • Manage remediation updates/ efforts within internal systems including generating reports or dashboards as needed.
    • Represent the organization as a primary contact for specific projects
    • Build submissions in company database for ease of access and maintenance.
    • Engage collaboratively with project teams and regional specialists which are comprised of personnel from regulatory, quality, clinical, R&D, and operation functions to ensure efficient execution of a shared strategy.
    • Remediate and maintain design dossier/ product technical files, ensure compliance and the timely and accurate filing of regulatory documentation.
    • Responsible for developing a global product regulatory strategy
    • Manage global regulatory strategies and impact assessments of changes that may impact the regulatory approvals.
    • Establish and maintain a professional and credible image with FDA and Notified Bodies i.e. TUV, and other regulatory agencies.
    • Act as liaison with International regulatory personnel to address questions and issues that arise as part of the registration process.
    • Organize regulatory information resources and tracks and controls submissions.
    • Develop a product regulatory timeline aligned to product development, with key regulatory milestone, and activities for submission 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/NB requirements and timing for submissions 
    • 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 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  specifically with respect to the US and EU Regions (i.e. EU Medical Device Directive (MDD) 93/42/EEC, and CE mark process)
    • Exposure to EU Medical Device Regulation (EU MDR) 2017/245.
    • 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 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
    • Medical device product remediation experience (i.e DHF, Technical Doc) preferred
    • 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
    • Excellent organizational and multi-project management skills, with specific attention to detail.
    • Travel is up to 20% of time
    • Minimum of 4 years relevant medical device industry and regulatory experience
    • Bachelor’s degree in science or health related field
    • Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

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