Endologix, Inc

Sr. Regulatory Affairs Specialist

Job ID
2017-1722
US-CA-Irvine

Overview

Represents the Regulatory Affairs function, and completes projects and tasks to established timelines to meet corporate objectives. Ensures compliance with state and/or global medical device regulations, as assigned, and overall regulatory department objectives. Negotiates the content and structure of regulatory filings with international partners, agents, and distributors. Develops, prepares, and maintains US and/or international regulatory filings and documentation and supports interactions with regulatory authorities to achieve timely approvals.

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.
    • Negotiates with international staff, agents, and distributors on technical data and submission filing contents.
    • 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.
    • Under the direction of Regulatory Affairs management, executes regulatory aspects for any field corrective actions in a timely, thorough, and transparent manner. Develops reports for submission to global regulatory authorities, and responds to requests for information.
    • Maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to project teams and management.
    • Updates departmental procedures as required

Qualifications

    • Good interpersonal skills including ability to interact with high degree of diplomacy.
    • Extensive knowledge of global medical device regulations.
    • Comprehensive knowledge of quality systems and relationship to business.
    • Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
    • Ability to facilitate and provide input 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, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities within the internal commitment dates.
    • Effective problem solving techniques.
    • Excellent applied thinking and technical writing skills.
    • Strong communication and organization skills required.
    • Expertise in Microsoft Office applications and charting programs.
    • Product development team experience.
    • Experience in developing and communicating global regulatory strategies.

Education:

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

Experience:

    • Minimum 5 years of experience with a Bachelor’s degree, 3 years of experience with a Master’s degree of directly relevant experience in Regulatory Affairs.
    • Experience with US Class III cardiovascular devices strongly preferred.

 

(To perform the job successfully, an individual should demonstrate the following competencies):

 

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

 

 

 

Equipment Use & Abilities Required:

 

·         Equipment Use:  Copy machines, fax machines, calculators and personal computers and computer terminals.

·         Computer Skills:  Software proficiency in Microsoft Office Suite.

·         Language Skills:  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

·         Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. 

·         Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form 

 

WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

 

The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings.  A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.

 

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected 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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