Endologix, Inc

Director Regulatory Affairs

Job ID
2017-1736
US-CA-Irvine

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.

 

Job Scope:

Oversees global regulatory affairs activities for assigned device (s) and/or geographies.  Designs, plans and executes business-aligned strategies for timely and high quality regulatory submissions in close collaboration with marketing, research and development, manufacturing, and clinical affairs partners for optimum achievement of corporate objectives. Manages and mentors regulatory affairs staff. Provides regulatory advice to other departments and executive management.  Provides expertise in the interpretation of regulations into practical and workable plans.  Together with direct reports, interacts with regulatory agencies. Ensures that the manufacturing facility maintains all required U.S. and International certifications.

 

Responsibilities

Major Duties: 

  • Manages and develops Endologix regulatory affairs personnel supporting the business.
  • Reviews and interprets existing or new external standards and regulatory requirements as they relate to Endologix products and processes.
  • Ensures that timely, risk-balanced regulatory strategic direction and advice, with contingencies, is provided to project teams and Executive Management to assure that regulatory and clinical requirements are incorporated into development processes.
  • Effectively manages and prepares regulatory documents and submissions to ensure timely approvals of products and processes in accordance with business strategies and marketing plans.
  • Maintains excellent working relationships with regulatory authorities.
  • Maintains international and local registrations and ensures compliance with all post-approval commitments.
  • Ensures corporate compliance for manufacturing licenses, government reporting requirements, etc.
  • Supports external inspections by the State of California, US FDA, notified body, and international regulatory authorities.
  • Develops and delivers presentations to Executive Management and company personnel for educational and communication purposes.
  • Participate actively in budgeting process and ensures department remains within approved budget.
  • Perform other duties as assigned by supervisor.

Qualifications

Education:

 

Bachelor’s degree in Engineering, Life Sciences or other technical discipline

 

Experience:

 

10 years of related work experience, including: 

  • Class III medical device regulatory affairs functions, preferably in cardiovascular products
  • Direct experience in writing investigational and marketing medical device applications for submission to US, European, and international regulatory authorities (e.g., Japan).
  • Direct experience managing technical writing aspects of regulatory affairs processes.

 

 

Specific Skills, Knowledge & Behaviors

 

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

 

CORE COMPETENCIES:

Supervisor Core Competencies:

1.     Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed

2.     Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results

3.     Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels

4.     Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level

5.     Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups , and looks at the company holistically

6.     External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products

7.     Continuous Improvement: Leverages best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self and team

8.     Problem Solving & Problem Prevention: Uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

9.     Accountability: Drives and focuses on results, takes initiative without direction, takes broad ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

 

 

Core Competencies:

10.  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

11.  Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

12.  Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

13.  Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

14.  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

15.  Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

16.  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

17.  Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

18.  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:

 

 

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

2.     Computer Skills:  Software proficiency in Microsoft Office Suite.

3.     Language Skills:  English

4.     Mathematical Skills:  

5.     Reasoning Ability:  Strong critical thinking and reasoning abilities.

 

 

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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