Endologix, Inc

  • Sr. Regulatory Affairs Specialist / Project Manager

    Job ID
    2018-1876
    Location
    US-CA-Irvine
    Category
    Regulatory
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

     

    This position is responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives, and for the timely completion of other assigned activities related to regulatory support activities worldwide.

    Responsibilities

    • Supports RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
    • Provide support to currently marketed products as necessary.  This includes reviewing labeling, promotional material, product changes, and determination of change on existing submissions and creation of submissions for changes requiring regulatory approval
    • In collaboration with RA Management, project teams and/or international partners, evaluates possible pathways to marketing authorization and recommends strategy and pathway that appropriately weighs the probability of success with potential risks to the business.
    • Reviews and approves document change orders (DCOs), manufacturing nonconformance documents,   technical documents, test protocols and reports, and other documents as a key member of assigned project teams.
    • Develops, prepares and submits high quality technical information for submission in geographies as assigned. Establishes timelines, manages sub-team meetings relevant to the regulatory processes, and ensures timely execution
    • Manage query resolution process using sound project management skills and to agreed upon timelines in collaboration with cross-functional technical teams
    • Directly interact with regulatory bodies in the US and/or internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible.
    • Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidances and ensure effective communication to the project teams and Management.
    • In conjunction with global regulatory partners (internal and external) and Regulatory Management, develop, justify, and document sound regulatory strategies to support corporate goals in assigned regions.
    • In collaboration with the regulatory team, manage interactions with international agents and distributors, where required as assigned, to clearly identify regulatory requirements and changes on an ongoing basis.
    • Updates departmental procedures as required

    Qualifications

    • Extensive knowledge of global medical device regulations.
    • Comprehensive knowledge of quality systems and relationship to business.
    • Ability to facilitate and provide leadership when interpreting regulatory standards and guidances.
    • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
    • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
    • Effective interpersonal skills/diplomacy and problem solving techniques.
    • Excellent applied thinking and technical writing skills.
    • Strong communication and organization skills required.
    • Product development team experience.
    • Experience in writing global regulatory strategies.

    Education:

    • Minimum bachelor’s degree in a scientific discipline or equivalent.

    Experience:

    • Minimum of 6 years relevant experience.

     

    Core Competencies:

    • Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
    • Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
    • Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
    • Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
    • Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
    • Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
    • Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
    • Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
    • Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

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